Breast CancerNCT06061835
Non-contrast Magnetic Resonance Angiography in Deep Inferior Epigastric Perforator Flap Breast Reconstruction Planning
A study testing Non-contrast MRA in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning. and CTA with iodine contrast in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning. in people with Breast Cancer and Postsurgical Acquired Absence of Organ, run by I.M. Sechenov First Moscow State Medical University at 2 sites in Russia.
Trial summary
The aim of this study is to evaluate the efficacy and safety of contrast-free magnetic resonance angiography (MRA) for deep inferior epigastric perforator flap planning. The investigators propose to perform a non-contrast MRA to achieve the following extremely important objectives: to avoid radiation exposure… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Postsurgical Acquired Absence of Organ
- What is being tested?
- Non-contrast MRA in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning. and CTA with iodine contrast in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 2 sitesRussia
- Study dates
- 6 May 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A female patients who underwent unilateral mastectomy due to breast cancer, in remission.
- At least 1 year after completion of radiotherapy.
- Non-inclusion Criteria:
- A history of abdominal donor site free flaps or abdominoplasty.
- Inability to give consent.
- The expander with magnetic ports, claustrophobia, pregnancy and breastfeeding.
- Patients with severe hypertension, COPD, autoimmune disorders, SLE or poorly regulated diabetes
- The presence of psychiatric illness preventing participation in the study.
Who cannot join
- Patient's pregnancy diagnosed during the research period.
- Patient's refusal of surgery, patient's refusal of further participation in the study.
- The presence of concomitant diseases preventing participation in the study.
Trial locations and contacts
2 sites in 1 country.
Russia2 sites, 2 recruiting
- Recruiting
Lancet Clinic
Moscow, 105066
Elina I. Abdeeva, MD, PhD, +79651112189, abdeeva_e_i@student.sechenov.ru
Dmitry V. Melnikov
- Recruiting
IMSechenovMMA
Moscow, 119435
Elina I Abdeeva, MD, +79651112189, abdeeva_e_i@student.sechenov.ru
Dmitry V. Melnikov, MD, PhD
About this study
Official title: Non-contrast Magnetic Resonance Angiography Efficacy and Safety Assessment for Perforators Mapping in Deep Inferior Epigastric Perforator Flap Breast Reconstruction
The aim of this study is to evaluate the efficacy and safety of contrast-free magnetic resonance angiography (MRA) for deep inferior epigastric perforator flap planning. The investigators propose to perform a non-contrast MRA to achieve the following extremely important objectives: to avoid radiation exposure, minimize the risk of potentially harmful effects of contrast agents, and reduce the cost of the study.The investigators assume that the use of non-contrast MRA following our protocol including certain patient's positioning, a special pulse scanning sequence and perforators' projection method is effective and allows mapping of perforators without injecting a potential harmful contrast agent.
Read the detailed description
Rationale. Contrast-free MRA is a new concept for preoperative planning in breast reconstruction that combines the advantages of magnetic resonance imaging (no ionising radiation exposure), requires no potentially harmful contrast agent, and at the same time is highly accurate.
Aim. The aim of the study is to evaluate the efficacy and safety of the contrast-free magnetic resonance angiography (MRA) for perforators mapping in deep inferior epigastric perforator flap planning.
Study design. A retro- and prospective non-randomised non-blinded cohort multicenter study is conducted at the at the Department of Plastic Surgery (Sechenov University, Moscow), and at the Department of Reconstructive and Plastic Surgery (Lancet Clinic, Moscow), with all patients recruited through a single surgical team and all imaging performed at a single institution.
Study population. The investigators plan to conduct a pilot phase of this study using non-contrast MRA in 100 patients and to compare imaging modalities used in deep inferior epigastric perforator flap breast reconstruction (computed tomography angiography with contrast, n=35 and non-contrast magnetic resonance angiography, n=100). Power analysis determine that no less than 35 patients in control group in this study considering 80 % power with 95 % significance. The first group (experimental, MRA "-" group) will be included patients who refused computed tomography angiography (CTA) with contrast due to a number of reasons such as fear of contrast agent administration, history of iodine allergy, fear of radiation exposure, etc was underwent MRA without contrast, and the second group (control, CTA "+" group) will be involved iodine-tolerance patients with healthy kidneys who underwent preoperative planning with a standard technique - CTA with IV iodine-containing contrast injection.
Interventions. Participants in first group (experimental, MRA "-" group) underwent preoperative planning with a contrast-free magnetic resonance angiography (MRA) using an improved contrast-free MRA protocol. MRA was performed on a magnetic resonance machine Philips Ingenia 1.5 T (Royal Philips, Netherlands). High accuracy is achieved by the following actions: certain preprocedural patient's preparation and positioning, special pulse scanning sequence and perforators projection method.
Preprocedural patient's preparation. The investigators added to the MRA protocol a requirement of performing the study on an empty stomach (at least 8 hours of fasting) in order to reduce gastrointestinal activity.
Modified type of patient positioning. The investigators suggest performing MRA scanning in the prone position in order to both limit abdominal wall movement (related to breathing, peristalsis, and aortic pulsation) and to provide the closest location of the target area (vessels) to the coil.
Furthermore, this move allowed to introduce a further trick that facilitated the surgeons' work at the marking stage: the investigators placed the patient on her abdomen on a 3D printed special mesh made of ABS (Acrylonitrile Butadiene Styrene) (the patent for invention № RU 2023118155). The mesh served as a coordinate system, crosshairs of which accommodate capsules with liquid (A), which allows obtaining on the image not only vessels but also all points of capsules to form a basic standardized mesh, coinciding on the image and on the patient's body that is necessary for the most precise and convenient way of marking.
Due to the image directly used for preoperative marking, the protocol of the MRA scans description was not used.
Special pulse sequence and additional series of MRA scans. MRA is performed on a magnetic resonance machine Philips Ingenia 1.5 T in the T2 pulse sequence (to increase the accuracy of muscle localization assessment and the point of vessel immersion into the muscle) at TR and TE using a fat-suppression program with no IV contrast injection, which allows receiving information from moving objects (including blood within the vascular lumen). The investigators have incorporated an additional series of T2 scans without fat suppression with high resolution (thickness of slices from 0.8 to 1.2 mm) and visualization of the muscle fibers, which allows us to determine the site where the vessels pierce the muscle, intramuscular course of the perforating vessels, and the topography of the area of interest with accurate determination of the perforating vessel relative to the anatomical landmarks.
Following scanning, the images were analysed by a plastic surgeon in the OsiriX 10.0 program. The main benefit of the images was extracted by creating multiplanar reconstructions (MPR) in Maximum Intensity Processing (MIP) mode. This mode allows the evaluation of the vessels in length, their lumen diameters and the study of their correlations and distances from each other for the purpose of target vessel selection.The MRA images required simultaneous evaluation in two planes: frontal and sagittal or frontal and axial. This allowed to the investigators to evaluate the localize the point of vessel immersion into the muscle, the extent and direction of the vessel in the muscle thickness and to localize the point of vessel penetration over the muscle with further direction of the vessel course and the point of communications between superficial and deep systems.
The second group participants (control, CTA "+"group) underwent the standard commonly used computed tomography angiography (CTA) IV (intravenous) iodine-containing contrast injection, and in the supine position. CTA was performed on a Toshiba Aquilion 64 CTA scan machine (Toshiba Medical Systems, Tokyo, Japan) according to the Research and Practical Center of Medical Radiology guidelines №12 from March 22, 2017.
Informed consent is obtained from each participant.
Main study parameters. The investigators plan to evaluate the results according to the following criteria: the concordance ratio, the overall operation time, the time of the pedicle cut, the length of the fascia incision, the intraoperative flap perfusion, the presence of early postoperative complications and their nature, the presence of emergent vascular revision surgery. In addition, the investigators plan to evaluate the following parameters: the flap ischemia time, the number of perforators included in the flap, the fact of superficial vein(s) inclusion in the flap, the length of the vascular pedicle.
- Being tested
- Non-contrast MRA in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning., CTA with iodine contrast in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning.
- Keywords
- Autologous breast reconstruction, Preoperative planning, Perforator mapping, Deep Inferior Epigastric Perforator Flap, Magnetic resonance angiography, Computed tomography angiography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-contrast MRA in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning.Other
Device: MRA scan Philips Ingenia 1.5 T (Royal Philips, Netherlands)
Preprocedural patient's preparation: the study was performed on an empty stomach (at least 8 hours of fasting).
Type of patient positioning. MRA scanning was performed in the prone position.
Additional devices. The investigators placed the patient on her abdomen on a special coordinate system mesh, for the most precise and convenient way of marking.
Scanning protocol. The investigators added T2 pulse sequence to increase the accuracy of muscle localization assessment and the point of vessel immersion into the muscle at TR and TE using a fat suppression program, wich allows receiving information from moving objects (including blood within the vascular lumen).
Scan viewer program. OsiriX 10.0 Release
CTA with iodine contrast in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning.Other
Device: Device: Toshiba Aquilion 64 CTA scan machine (Toshiba Medical Systems, Tokyo, Japan).
Preprocedural patient's preparation: A catheter was placed in the antecubital vein of one arm, and a bolus injection of 80 ml contrast medium (Omnipaque 300 mg/ml, GE Healthcare, Oslo, Norway, registration number P N015799/01 from July 31, 2003, international nonproprietary name is a Iohexol) was administered through a power injector (M. Schilling GmbH Medical Products, Germany) at 4 ml/s.
Type of patient positioning. CTA scanning was performed in the supine position.
Scan viewer program. OsiriX 10.0 Release
| Study group | Role | What they receive |
|---|---|---|
| Non-contrast MRA (MRA "-") | Experimental | Participants in this group underwent preoperative planning with a contrast-free magnetic resonance angiography (MRA) using an enhanced protocol that eliminates the use of potentially hazardous contrast agent and radiation exposure while providing high accuracy of visualization. Receives: Other: Non-contrast MRA in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning. |
| CTA with contrast (CTA "+") | Other | Control group. Participants in this group underwent preoperative planning using the standard commonly used method - computed tomography angiography (CTA) with IV (intravenous) iodine-containing contrast injection. Receives: Other: CTA with iodine contrast in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concordance ratio.
The investigators are use the information about each perforators' deviation (P1, P2, etc.) based on intraoperative finding (confirmation) and MRA or CTA data by more/less than 1 cm.
Intraoperatively, the surgeon determined the distance from the umbilicus to the perforator vessel (by dropping a perpendicular line from umbilicus) and the distance from the point marked on the marking according to the MRA or CTA data to the found perforator vessel. Measurements performed using a 200 mm surgical ruler (Devemed, Germany).
Measured: During the surgery.
The overall operation time (min).
The total operating time including downtime.
Measured: Immediately after the surgery.
The time of the pedicle cut (min).
The investigators plan to evaluate the time of the pedicle cut from the beginning of surgery and from flap harvest, for the right and left vascular pedicle individually.
Measured: During the surgery.
The length of the fascia incision (cm).
Intraoperatively, the surgeon measured the fascia incision length using a 200 mm surgical ruler (Devemed, Germany).
Measured: During the surgery.
Intraoperative evaluation of flap perfusion.
The flap perfusion was assessed for capillary refill after the vascular pedicle clipping, after the vascular pedicle cutting, and at the end of the flap ischemia time (after the microvascular anastomosis formation) by applying mild pressure, using a hemostat handle. Pressure was then released and the flap observed for capillary refill. Refill was deemed positive if it occurred within 3 s.
Measured: During the surgery.
Postoperative flap necrosis (%).
The presence of flap necrosis was assessed during the first five days after surgery by evaluating capillary refill in thee flap and visually assessed the presence of the flap ischemia or necrosis as a percentage of the total flap.
Measured: During the first week after surgery.
Secondary outcomes (4)
The flap ischemia time (min).
Flap ischemia time was assessed from the time of vascular pedicle cutoff to completion of microvascular anastomosis formation ( up to the beginning of blood flow).
Measured: During the surgery.
The length of the vascular pedicle (cm).
After flap harvesting, the surgeon measured the vascular pedicle length using a 200 mm surgical ruler (Devemed, Germany).
Measured: During the surgery.
The number of perforators included in the flap.
The investigators recorded the number of perforators included in the flap on each side of the flap.
Measured: Immediately after the surgery.
Inclusion of superficial vein(s) in the flap.
The investigators recorded the fact of the superficial vein(s) inclusion in the flap, their number and localization (side of the flap).
Measured: Immediately after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start6 May 2023
- Primary completion10 Feb 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.M. Sechenov First Moscow State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dmitry V. Melnikov, MD, PhD, Principal investigator, I.M. Sechenov First Moscow State Medical UniversityVictor A. Gombolevskiy, MD, PhD, Principal investigator, Artificial Intelligence Research Institute (AIRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061835
- Sponsor's protocol ID
- MD05052023
- Other IDs
- Patent № RU 2023121330
- Status last verified
- Jul 2023
- First submitted
- 16 Sep 2023
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the local ethics committee the investigators are unable to provide this data.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-contrast Magnetic Resonance Angiography Efficacy and Safety Assessment for Perforators Mapping in Deep Inferior Epigastric Perforator Flap Breast Reconstruction
- ClinicalTrials.gov ID
- NCT06061835
- Acronym / sponsor ID
- MD05052023
- Keywords
- Autologous breast reconstruction, Preoperative planning, Perforator mapping, Deep Inferior Epigastric Perforator Flap, Magnetic resonance angiography, Computed tomography angiography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- I.M. Sechenov First Moscow State Medical UniversityUniversity, hospital or other
- Study start
- 6 May 2023 (actual)
- Primary completion
- 10 Feb 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the efficacy and safety of contrast-free magnetic resonance angiography (MRA) for deep inferior epigastric perforator flap planning. The investigators propose to perform a non-contrast MRA to achieve the following extremely important objectives: to avoid radiation exposure, minimize the risk of potentially harmful effects of contrast agents, and reduce the cost of the study.The investigators assume that the use of non-contrast MRA following our protocol including certain patient's positioning, a special pulse scanning sequence and perforators' projection method is effective and allows mapping of perforators without injecting a potential harmful contrast agent.
Detailed description
Rationale. Contrast-free MRA is a new concept for preoperative planning in breast reconstruction that combines the advantages of magnetic resonance imaging (no ionising radiation exposure), requires no potentially harmful contrast agent, and at the same time is highly accurate.
Aim. The aim of the study is to evaluate the efficacy and safety of the contrast-free magnetic resonance angiography (MRA) for perforators mapping in deep inferior epigastric perforator flap planning.
Study design. A retro- and prospective non-randomised non-blinded cohort multicenter study is conducted at the at the Department of Plastic Surgery (Sechenov University, Moscow), and at the Department of Reconstructive and Plastic Surgery (Lancet Clinic, Moscow), with all patients recruited through a single surgical team and all imaging performed at a single institution.
Study population. The investigators plan to conduct a pilot phase of this study using non-contrast MRA in 100 patients and to compare imaging modalities used in deep inferior epigastric perforator flap breast reconstruction (computed tomography angiography with contrast, n=35 and non-contrast magnetic resonance angiography, n=100). Power analysis determine that no less than 35 patients in control group in this study considering 80 % power with 95 % significance. The first group (experimental, MRA "-" group) will be included patients who refused computed tomography angiography (CTA) with contrast due to a number of reasons such as fear of contrast agent administration, history of iodine allergy, fear of radiation exposure, etc was underwent MRA without contrast, and the second group (control, CTA "+" group) will be involved iodine-tolerance patients with healthy kidneys who underwent preoperative planning with a standard technique - CTA with IV iodine-containing contrast injection.
Interventions. Participants in first group (experimental, MRA "-" group) underwent preoperative planning with a contrast-free magnetic resonance angiography (MRA) using an improved contrast-free MRA protocol. MRA was performed on a magnetic resonance machine Philips Ingenia 1.5 T (Royal Philips, Netherlands). High accuracy is achieved by the following actions: certain preprocedural patient's preparation and positioning, special pulse scanning sequence and perforators projection method.
Preprocedural patient's preparation. The investigators added to the MRA protocol a requirement of performing the study on an empty stomach (at least 8 hours of fasting) in order to reduce gastrointestinal activity.
Modified type of patient positioning. The investigators suggest performing MRA scanning in the prone position in order to both limit abdominal wall movement (related to breathing, peristalsis, and aortic pulsation) and to provide the closest location of the target area (vessels) to the coil.
Furthermore, this move allowed to introduce a further trick that facilitated the surgeons' work at the marking stage: the investigators placed the patient on her abdomen on a 3D printed special mesh made of ABS (Acrylonitrile Butadiene Styrene) (the patent for invention № RU 2023118155). The mesh served as a coordinate system, crosshairs of which accommodate capsules with liquid (A), which allows obtaining on the image not only vessels but also all points of capsules to form a basic standardized mesh, coinciding on the image and on the patient's body that is necessary for the most precise and convenient way of marking.
Due to the image directly used for preoperative marking, the protocol of the MRA scans description was not used.
Special pulse sequence and additional series of MRA scans. MRA is performed on a magnetic resonance machine Philips Ingenia 1.5 T in the T2 pulse sequence (to increase the accuracy of muscle localization assessment and the point of vessel immersion into the muscle) at TR and TE using a fat-suppression program with no IV contrast injection, which allows receiving information from moving objects (including blood within the vascular lumen). The investigators have incorporated an additional series of T2 scans without fat suppression with high resolution (thickness of slices from 0.8 to 1.2 mm) and visualization of the muscle fibers, which allows us to determine the site where the vessels pierce the muscle, intramuscular course of the perforating vessels, and the topography of the area of interest with accurate determination of the perforating vessel relative to the anatomical landmarks.
Following scanning, the images were analysed by a plastic surgeon in the OsiriX 10.0 program. The main benefit of the images was extracted by creating multiplanar reconstructions (MPR) in Maximum Intensity Processing (MIP) mode. This mode allows the evaluation of the vessels in length, their lumen diameters and the study of their correlations and distances from each other for the purpose of target vessel selection.The MRA images required simultaneous evaluation in two planes: frontal and sagittal or frontal and axial. This allowed to the investigators to evaluate the localize the point of vessel immersion into the muscle, the extent and direction of the vessel in the muscle thickness and to localize the point of vessel penetration over the muscle with further direction of the vessel course and the point of communications between superficial and deep systems.
The second group participants (control, CTA "+"group) underwent the standard commonly used computed tomography angiography (CTA) IV (intravenous) iodine-containing contrast injection, and in the supine position. CTA was performed on a Toshiba Aquilion 64 CTA scan machine (Toshiba Medical Systems, Tokyo, Japan) according to the Research and Practical Center of Medical Radiology guidelines №12 from March 22, 2017.
Informed consent is obtained from each participant.
Main study parameters. The investigators plan to evaluate the results according to the following criteria: the concordance ratio, the overall operation time, the time of the pedicle cut, the length of the fascia incision, the intraoperative flap perfusion, the presence of early postoperative complications and their nature, the presence of emergent vascular revision surgery. In addition, the investigators plan to evaluate the following parameters: the flap ischemia time, the number of perforators included in the flap, the fact of superficial vein(s) inclusion in the flap, the length of the vascular pedicle.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-contrast MRA (MRA "-") | Experimental | Other: Non-contrast MRA in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning.Participants in this group underwent preoperative planning with a contrast-free magnetic resonance angiography (MRA) using an enhanced protocol that eliminates the use of potentially hazardous contrast agent and radiation exposure while providing high accuracy of visualization. |
| CTA with contrast (CTA "+") | Other | Other: CTA with iodine contrast in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning.Control group. Participants in this group underwent preoperative planning using the standard commonly used method - computed tomography angiography (CTA) with IV (intravenous) iodine-containing contrast injection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A female patients who underwent unilateral mastectomy due to breast cancer, in remission.
- At least 1 year after completion of radiotherapy.
- A history of abdominal donor site free flaps or abdominoplasty.
- Inability to give consent.
- The expander with magnetic ports, claustrophobia, pregnancy and breastfeeding.
Key exclusion criteria (3 listed)
- Patient's pregnancy diagnosed during the research period.
- Patient's refusal of surgery, patient's refusal of further participation in the study.
- The presence of concomitant diseases preventing participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-contrast MRA in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning.Device: MRA scan Philips Ingenia 1.5 T (Royal Philips, Netherlands) Preprocedural patient's preparation: the study was performed on an empty stomach (at least 8 hours of fasting). Type of patient positioning. MRA scanning was performed in the prone position. Additional devices. The investigators placed the patient on her abdomen on a special coordinate system mesh, for the most precise and convenient way of marking. Scanning protocol. The investigators added T2 pulse sequence to increase the accuracy of muscle localization assessment and the point of vessel immersion into the muscle at TR and TE using a fat suppression program, wich allows receiving information from moving objects (including blood within the vascular lumen). Scan viewer program. OsiriX 10.0 Release | Other | Non-contrast MRA (MRA "-") |
| CTA with iodine contrast in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning.Device: Device: Toshiba Aquilion 64 CTA scan machine (Toshiba Medical Systems, Tokyo, Japan). Preprocedural patient's preparation: A catheter was placed in the antecubital vein of one arm, and a bolus injection of 80 ml contrast medium (Omnipaque 300 mg/ml, GE Healthcare, Oslo, Norway, registration number P N015799/01 from July 31, 2003, international nonproprietary name is a Iohexol) was administered through a power injector (M. Schilling GmbH Medical Products, Germany) at 4 ml/s. Type of patient positioning. CTA scanning was performed in the supine position. Scan viewer program. OsiriX 10.0 Release | Other | CTA with contrast (CTA "+") |
Primary outcome
The concordance ratio.
Time frame: During the surgery.
The investigators are use the information about each perforators' deviation (P1, P2, etc.) based on intraoperative finding (confirmation) and MRA or CTA data by more/less than 1 cm. Intraoperatively, the surgeon determined the distance from the umbilicus to the perforator vessel (by dropping a perpendicular line from umbilicus) and the distance from the point marked on the marking according to the MRA or CTA data to the found perforator vessel. Measurements performed using a 200 mm surgical ruler (Devemed, Germany).
The overall operation time (min).
Time frame: Immediately after the surgery.
The total operating time including downtime.
The time of the pedicle cut (min).
Time frame: During the surgery.
The investigators plan to evaluate the time of the pedicle cut from the beginning of surgery and from flap harvest, for the right and left vascular pedicle individually.
The length of the fascia incision (cm).
Time frame: During the surgery.
Intraoperatively, the surgeon measured the fascia incision length using a 200 mm surgical ruler (Devemed, Germany).
Intraoperative evaluation of flap perfusion.
Time frame: During the surgery.
The flap perfusion was assessed for capillary refill after the vascular pedicle clipping, after the vascular pedicle cutting, and at the end of the flap ischemia time (after the microvascular anastomosis formation) by applying mild pressure, using a hemostat handle. Pressure was then released and the flap observed for capillary refill. Refill was deemed positive if it occurred within 3 s.
Postoperative flap necrosis (%).
Time frame: During the first week after surgery.
The presence of flap necrosis was assessed during the first five days after surgery by evaluating capillary refill in thee flap and visually assessed the presence of the flap ischemia or necrosis as a percentage of the total flap.
4 secondary outcomes
The flap ischemia time (min).
Time frame: During the surgery.
The length of the vascular pedicle (cm).
Time frame: During the surgery.
The number of perforators included in the flap.
Time frame: Immediately after the surgery.
Inclusion of superficial vein(s) in the flap.
Time frame: Immediately after the surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Individual participant dataSharing planned: No. Due to the local ethics committee the investigators are unable to provide this data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dmitry V. Melnikov, MD, PhD principal investigator
I.M. Sechenov First Moscow State Medical University
Victor A. Gombolevskiy, MD, PhD principal investigator
Artificial Intelligence Research Institute (AIRI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-contrast MRA in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning. and CTA with iodine contrast in preoperative perforator vessels mapping for deep inferior epigastric perforator (DIEP) flap breast reconstruction planning. in people with Breast Cancer and Postsurgical Acquired Absence of Organ, run by I.M. Sechenov First Moscow State Medical University at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elina I. Abdeeva, MD (+79651112189, abdeeva_e_i@student.sechenov.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The concordance ratio. (time frame: During the surgery.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.