Breast CancerSPYNCT02144961
The Effects of Indocyanine Green Angiography (IGA) on Deep Inferior Epigastric Artery Perforator (DIEP) Flap Design and Post-Operative Fat Necrosis
An observational study of Breast Cancer, run by University of Washington at 1 site in United States.
Trial summary
The aim of this study is to prospectively evaluate the effect of intra-operative Indocyanine green angiography (IGA) on both flap design and rate of post-operative fat necrosis in patients undergoing autologous breast reconstruction utilizing the Deep Inferior Epigastric Artery Perforator (DIEP) flap. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Sep 2020
- Phase
- Observational
- 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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Females pursuing breast reconstruction after having undergone mastectomy. In the overwhelming majority of cases, this procedure is indicated for breast cancer treatment. Eligible patients will have their breast reconstruction done at the University of Washington Medical Center.
Who may be able to join
- Female patients at the University of Washington
- Aged twenty-five to sixty-five years
- Pursuing immediate or delayed, DIEP-based, autologous, microsurgical breast reconstruction at the University of Washington Medical Center
Who cannot join
- Patients unsuitable for autologous, microsurgical breast reconstruction utilizing the DIEP flap - i.e. patients who have undergone prior extensive abdominal surgeries, have inadequate abdominal tissue bulk, who cannot comply with standardized post-operative restrictions / assessments or patients afflicted with a medical condition(s) precluding prolonged general anesthesia and surgery.
- Patients who have a known allergy to contrast media will also be excluded from this study.
- Patients unable to read and write in English will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Official title: Observational Study to Compare Research-only Breast Ultrasound to Standard of Care Physical Exam for Identifying Tissue Necrosis in Post-mastectomy Patients Undergoing Planned Breast Reconstruction.
The aim of this study is to prospectively evaluate the effect of intra-operative Indocyanine green angiography (IGA) on both flap design and rate of post-operative fat necrosis in patients undergoing autologous breast reconstruction utilizing the Deep Inferior Epigastric Artery Perforator (DIEP) flap.
Read the detailed description
For many post-mastectomy cancer patients seeking breast reconstruction, microsurgical, autologous tissue transfer is a desirable alternative to more conventional, implant-based procedures. In general terms, this technique entails use of one's own tissue, transferred from a distant anatomic site, to recreate the absent breast. This tissue, usually a composite of skin and subcutaneous adipose tissue, is isolated along with its source artery and vein, and transferred to the chest wall where it is connected (anastomosed) to a local blood supply.
Though there have been many donor tissues (flaps) described for this purpose, abdominal tissue supplied by small, perforating blood vessels originating from the deep inferior epigastric artery, has become the microsurgical gold standard. This so-called DIEP flap provides abundant tissue that can be easily sculpted to fill most breast defects with minimal donor site morbidity. Like all microvascular, free tissue transfers, however, the DIEP flap is not without its potential complications. One potential complication that is most distressing to patients occurs when a portion of the subcutaneous adipose tissue transferred exceeds the available blood supply. This devascularized fat eventually undergoes necrosis that may not only complicate the interpretation of future mammograms, but may result in palpable, painful, and occasionally visible, irregularities within the transferred tissue. Though many techniques/interventions/technologies have been described to minimize the incidence of fat necrosis, its occurrence remains frustratingly unpredictable and relatively common, with published rates ranging between 6 and 17 %.
In theory, maximizing perfusion to composite tissue flaps should minimize the rate of fat necrosis. As such, many techniques have emerged in DIEP flap surgery intended to maximize perfusion. One common technique is the use of pre-operative, CT angiography (CTA) to identify the largest and most anatomically favorable perforating vessels to include in the composite tissue transferred. Though elegant in its simplicity, use of this technique has never been demonstrated to decrease the rate of fat necrosis in DIEP reconstructions. In recent years, however, another technology intended to intra-operatively evaluate tissue perfusion has emerged that may prove very beneficial in the realm of microvascular free tissue transfer- Indocyanine green angiography (IGA).
IGA refers to the peripheral venous injection of lyophilized indocyanine green, a contrast agent that fluoresces when excited by a laser of specific wavelength A charge-coupled camera, held above the tissue of interest, can then detect the stimulated fluorescence and project an image of "real-time" tissue perfusion that is proportional to emission intensity. The application of IGA technology in reconstructive plastic surgery, a discipline that relies largely on immediate and accurate assessment of tissue perfusion, has recently generated much discussion.
We believe that perforator selection in DIEP breast reconstructions, a process traditionally dictated at our institution by pre-operative CTA, may be heavily influenced by intra-operative IGA. We further hypothesize that use of intra-operative IGA in DIEP breast reconstructions may reduce the incidence of post-operative fat necrosis.
The aim of this study is to prospectively evaluate the effect of intra-operative Indocyanine Green Angiography (IGA) on both flap design and rate of post-operative fat necrosis in patients undergoing autologous breast reconstruction utilizing the Deep Inferior Epigastric Artery Perforator (DIEP) flap.
- Conditions
- Breast Cancer
- Keywords
- breast reconstruction, Deep Inferior Epigastric Artery Perforator (DIEP), Indocyanine Green Angiography (IGA), autologous tissue transfer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound | Breast ultrasound in female patients who are post-mastectomy pursuing autologous tissue breast reconstruction surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of post-operative fat necrosis
Prospectively evaluate the effect of intra-operative IGA on both DIEP flap design, and rate of post-operative DIEP fat necrosis as compared by physical exam and breast ultrasound.
Measured: 3-6 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2017 (estimated)
- Study completionSep 2020 (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.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Skye Stewart, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144961
- Sponsor's protocol ID
- 45728-A
- Acronym
- SPY
- Status last verified
- Mar 2016
- First submitted
- 19 May 2014
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Compare Research-only Breast Ultrasound to Standard of Care Physical Exam for Identifying Tissue Necrosis in Post-mastectomy Patients Undergoing Planned Breast Reconstruction.
- ClinicalTrials.gov ID
- NCT02144961
- Acronym / sponsor ID
- SPY / 45728-A
- Conditions
- Breast Cancer
- Keywords
- breast reconstruction, Deep Inferior Epigastric Artery Perforator (DIEP), Indocyanine Green Angiography (IGA), autologous tissue transfer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 22 May 2014 (estimated)
- 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 prospectively evaluate the effect of intra-operative Indocyanine green angiography (IGA) on both flap design and rate of post-operative fat necrosis in patients undergoing autologous breast reconstruction utilizing the Deep Inferior Epigastric Artery Perforator (DIEP) flap.
Detailed description
For many post-mastectomy cancer patients seeking breast reconstruction, microsurgical, autologous tissue transfer is a desirable alternative to more conventional, implant-based procedures. In general terms, this technique entails use of one's own tissue, transferred from a distant anatomic site, to recreate the absent breast. This tissue, usually a composite of skin and subcutaneous adipose tissue, is isolated along with its source artery and vein, and transferred to the chest wall where it is connected (anastomosed) to a local blood supply.
Though there have been many donor tissues (flaps) described for this purpose, abdominal tissue supplied by small, perforating blood vessels originating from the deep inferior epigastric artery, has become the microsurgical gold standard. This so-called DIEP flap provides abundant tissue that can be easily sculpted to fill most breast defects with minimal donor site morbidity. Like all microvascular, free tissue transfers, however, the DIEP flap is not without its potential complications. One potential complication that is most distressing to patients occurs when a portion of the subcutaneous adipose tissue transferred exceeds the available blood supply. This devascularized fat eventually undergoes necrosis that may not only complicate the interpretation of future mammograms, but may result in palpable, painful, and occasionally visible, irregularities within the transferred tissue. Though many techniques/interventions/technologies have been described to minimize the incidence of fat necrosis, its occurrence remains frustratingly unpredictable and relatively common, with published rates ranging between 6 and 17 %.
In theory, maximizing perfusion to composite tissue flaps should minimize the rate of fat necrosis. As such, many techniques have emerged in DIEP flap surgery intended to maximize perfusion. One common technique is the use of pre-operative, CT angiography (CTA) to identify the largest and most anatomically favorable perforating vessels to include in the composite tissue transferred. Though elegant in its simplicity, use of this technique has never been demonstrated to decrease the rate of fat necrosis in DIEP reconstructions. In recent years, however, another technology intended to intra-operatively evaluate tissue perfusion has emerged that may prove very beneficial in the realm of microvascular free tissue transfer- Indocyanine green angiography (IGA).
IGA refers to the peripheral venous injection of lyophilized indocyanine green, a contrast agent that fluoresces when excited by a laser of specific wavelength A charge-coupled camera, held above the tissue of interest, can then detect the stimulated fluorescence and project an image of "real-time" tissue perfusion that is proportional to emission intensity. The application of IGA technology in reconstructive plastic surgery, a discipline that relies largely on immediate and accurate assessment of tissue perfusion, has recently generated much discussion.
We believe that perforator selection in DIEP breast reconstructions, a process traditionally dictated at our institution by pre-operative CTA, may be heavily influenced by intra-operative IGA. We further hypothesize that use of intra-operative IGA in DIEP breast reconstructions may reduce the incidence of post-operative fat necrosis.
The aim of this study is to prospectively evaluate the effect of intra-operative Indocyanine Green Angiography (IGA) on both flap design and rate of post-operative fat necrosis in patients undergoing autologous breast reconstruction utilizing the Deep Inferior Epigastric Artery Perforator (DIEP) flap.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound | – | –Breast ultrasound in female patients who are post-mastectomy pursuing autologous tissue breast reconstruction surgery. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Females pursuing breast reconstruction after having undergone mastectomy. In the overwhelming majority of cases, this procedure is indicated for breast cancer treatment. Eligible patients will have their breast reconstruction done at the University of Washington Medical Center.
Key inclusion criteria (3 listed)
- Female patients at the University of Washington
- Aged twenty-five to sixty-five years
- Pursuing immediate or delayed, DIEP-based, autologous, microsurgical breast reconstruction at the University of Washington Medical Center
Key exclusion criteria (3 listed)
- Patients unsuitable for autologous, microsurgical breast reconstruction utilizing the DIEP flap - i.e. patients who have undergone prior extensive abdominal surgeries, have inadequate abdominal tissue bulk, who cannot comply with standardized post-operative restrictions / assessments or patients afflicted with a medical condition(s) precluding prolonged general anesthesia and surgery.
- Patients who have a known allergy to contrast media will also be excluded from this study.
- Patients unable to read and write in English will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of post-operative fat necrosis
Time frame: 3-6 months post-operatively
Prospectively evaluate the effect of intra-operative IGA on both DIEP flap design, and rate of post-operative DIEP fat necrosis as compared by physical exam and breast ultrasound.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Washington at 1 site in United States.
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 3 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 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of post-operative fat necrosis (time frame: 3-6 months post-operatively). 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 24 Mar 2016.