Breast CancerSENTINEONCT05625698
Premarking of Axillary Nodes Before Start of Neoadjuvant Chemotherapy Using Magnetic Approach
A study testing MagTrace only and MagTrace and Magseed in people with Breast Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
Breast cancer is one of the commonest types of cancers in females. Treatments include surgery followed by anti-estrogen therapy, radiotherapy and chemotherapy. During breast surgery, the surgeon removes the cancer from the breast and lymph nodes (glands) from the armpit. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MagTrace only and MagTrace and Magseed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2021to 28 Nov 2023
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A patient meeting the following criteria is eligible for participation in the study:
- Patients 18 years of age or older
- Patients with breast cancer planned to undergo preoperative chemotherapy (NACT) with a) planned sentinel lymph node biopsy (SNB) or b) axillary lymph node dissection, in conjunction with the beast surgery after NACT
Who cannot join
- Intolerance / hypersensitivity to iron or dextran compounds or SPIO.
- Patients who are required to undergo MR to evaluate tumour response
- Pregnancy or breast feeding
- Patients with an iron overload disease.
- Patient deprived of liberty or under guardianship.
- Inability to understand given information, give informed consent, undergo study procedures
- MRI (subgroup of patients): Conditions contraindicating MRI including, but not limited to, BMI > 40 kg/m2, claustrophobia, metallic implants or internal electrical devices (e.g. Pacemaker).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Axillary Lymph Node Identification Before Neoadjuvant Chemotherapy Using MagTrace (Superparamagnetic Iron Oxide Nanoparticles, SPIO) and Magseed, in Clinically Node Negative and Node Positive Patients: a Feasibility Study.
Breast cancer is one of the commonest types of cancers in females. Treatments include surgery followed by anti-estrogen therapy, radiotherapy and chemotherapy. During breast surgery, the surgeon removes the cancer from the breast and lymph nodes (glands) from the armpit.
Historically, all armpit lymph nodes were surgically removed but this approach is associated long term problems of arm swelling. In more recent times, an increasingly more selective approach is used to treat the armpit nodes. In the presence of cancer spreads in the nodes, an axillary clearance surgery is done otherwise, only the first node(s) also called sentinel node(s) that drain fluids from the cancer, is surgically removed. The identification of nodes using the latter approach is helped by injecting a tracer in the breast and via the lymphatic channels, the tracer is then concentrated in the sentinel nodes.
Read more
Over recent years, neoadjuvant (preoperative) chemotherapy is being increasingly used to treat breast cancers. This treatment approach can lead up to a large of number of complete cancer response. This in turn can cause difficulties in locating the breast cancer / armpit nodes during surgery after the chemotherapy.
New developments like superparamagnetic iron oxide nanoparticles (SPIO or MagTrace®) has been used as an alternate liquid tracer to mark sentinel nodes to facilitate armpit surgery. In addition, small magnetic clip called Magseed® has also been developed which can be inserted into the relevant lymph nodes thereby marking their anatomical position to facilitate surgery. Both MagTrace and Magseed can be used to pre-mark the cancer and armpit nodes before the start of neoadjuvant chemotherapy. In theory, premarking armpit nodes using a magnetic approach is associated with better surgical accuracy in the armpit but there is limited supporting data.
Therefore, this study aims to investigate the feasibility of premarking armpit nodes, with or without cancer spread, using magtrace and magseed respectively before patients undergo neoadjuvant chemotherapy.
Read the detailed description
Breast cancer is one of the commonest types of cancers in females. Treatments include surgery followed by anti-estrogen therapy (tablet form), radiotherapy (radiation) and chemotherapy (intravenous / tablet form). During breast surgery, the surgeon removes the cancer from the breast and lymph nodes (glands) from the armpit.
Historically, all armpit lymph nodes (clearance) were removed irrespective of the stage of armpit disease which can lead to over-treatment and unnecessary long term arm lymphoedema (swelling). However, the modern approach has become more selective. If there are cancer spread in the nodes at diagnosis, a clearance operation is carried out otherwise only the first node(s) that the cancer spreads to, is removed. The latter procedure is called sentinel node biopsy and it is usually done by injecting a radioactive liquid tracer near the breast cancer. The tracer is then drained via the breast lymphatic channels and concentrated in the relevant armpit nodes where it can be detected by using a detector probe during surgery.
In recent years, there are increasing uses of preoperative (neoadjuvant, NACT) chemotherapy in certain breast cancer subtypes with good cancer response. In up to 70% of cases, the treated cancer had disappeared both, in the breast and armpit, after NACT. Consequently, it can be difficult to locate and surgically remove these nodes in the armpits even with the usual injection of tracer after NACT. These difficulties are due to the damage of lymphatic channels in the breast by NACT and become fibrotic. Therefore, the tracer injected after NACT will no longer be drained correctly to mark the correct nodes in the armpit as the lymphatic channels are altered. In turn, this can lead to wrong sentinel nodes being removed from the armpit, which then can cause inaccurate planning for further treatments.
Over recent times, superparamagnetic iron oxide nanoparticles (SPIO or MagTrace®) has been used as an alternate liquid tracer to mark sentinel nodes to facilitate armpit surgery. In addition, small magnetic clip called Magseed® has also been developed. Magseed® can be directly inserted into the relevant lymph nodes thereby marking their anatomical position to facilitate surgery. Both MagTrace and Magseed are longer lasting materials in the body than the radioactive technetium. Therefore, these new techniques give rise to an opportunity to premark the armpit nodes before the damage to lymphatic channels (with MagTrace) and before the cancer in the nodes disappear (with magseed), after NACT. In theory, premarking armpit nodes using a magnetic approach is associated with better surgical accuracy in the armpit but there is limited supporting data.
Therefore, this study aims to investigate the feasibility of injecting MagTrace before NACT and then identify the sentinel node at surgery, three to six months later. The aim is also to investigate if a metastatic lymph node can be marked with Magseed® before NACT and together with MagTrace identify the metastatic node, as well as additional sentinel nodes at surgery, three to six months later.
The overall aim is to facilitate logistics at surgery, finding the right SN and minimize axillary surgery.
OBJECTIVES:
Primary objectives:
- Cohort 1, Node Negative Patients before NACT: To evaluate the SN detection rate with Magtrace® injected before NACT
- Cohort 2, Node Positive Patients before NACT: To evaluate per-operative identification and removal rate of a Magseed clipped metastatic index lymph node
Secondary objectives:
- Node Negative Patients before NACT: To evaluate the concordance of SN detection by Magtrace® injected before NACT and Technetium (Tc99) +/- blue dye (BD) injected after NACT, respectively
- Node Positive Patients before NACT: To evaluate:
- the SN detection rate with Magtrace® injected before NACT
- the concordance of SNs detected by Magtrace® injected before NACT and Tc99 + BD injected after NACT, during targeted axillary dissection (TAD)
- the number of metastatic SNs and metastatic additional lymph nodes from the axillary dissection
ENDPOINTS:
Primary endpoints:
- Cohort 1, SN detection rate
- Cohort 2, Identification rate and removal rate of clipped index metastatic lymph node
Secondary endpoints:
- Cohort 1, Concordance of SNs identified with Magtrace and Tc99 after NACT
- Cohort 2, a) SN detection rate. b) Concordance of SNs identified with MagTrace and Tc99 after NACT. c) Number of metastatic lymph nodes among SNs and additional lymph nodes
- Cohort 1+2, Incidence of serious adverse events (SAEs).
- Conditions
- Breast Cancer
- Being tested
- MagTrace only, MagTrace and Magseed
- Keywords
- neoadjuvant chemotherapy, sentinel node, axillary clearance
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagTrace onlyDrug
Also called SPIO
see information in arm descriptions
MagTrace and MagseedCombination product
Also called SPIO
see information in arm descriptions
| Study group | Role | What they receive |
|---|---|---|
| MagTrace only | Other | Cohort 1: Clinically node negative patients undergoing neoadjuvant chemotherapy. This cN0-group will receive MagTrace injections before start of neoadjuvant chemotherapy followed standard routine technetium-99 injections after neoadjuvant chemotherapy to facilitate surgery. Nodes containing Magtrace will be detected by finding the magnetic signals using the SentiMag probe. No other interventions during chemotherapy treatments Receives: Drug: MagTrace only |
| MagTrace and Magseed | Other | Cohort 2: Clinically node positive patients undergoing neoadjuvant chemotherapy. This N+ group will receive MagTrace injection in the breast to mark sentinel nodes and Magseed will be inserted into the index metastatic node before the start of neoadjuatnt chemotherapy followed by standard routine technetium-99 injections after neoadjuvant chemotherapy to facilitate surgery. Nodes containing Magtrace / Magseed will be detected by finding the magnetic signals using the SentiMag probe. No other interventions during chemotherapy treatments Receives: Combination Product: MagTrace and Magseed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of axillary sentinel node after neoadjuvant chemotherapy
Cohort 1: Patients with clinically node negative axillary nodes who undergo neoadjuatnt chemotherapy- Injected with Magtrace (magnetic non particles) near the breast cancer. Detection rate of SN using magtrace to be compared with there rate using the standard comparator Technetium-99
Measured: Time between injection of magnetic tracer and technetium-99 is between 3-4 months-
Detection rate of pre-marked metastatic axillary node(s) with magseed after neoadjuvant chemotherapy
Cohort 2: Patients with clinically node positive axillary nodes who undergo neoadjuatnt chemotherapy- Injected with Magtrace (magnetic non particles) near the breast cancer. Detection rate of SN using magtrace to be compared with there rate using the standard comparator Technetium-99
Measured: Time between magseed insertion of magnetic tracer and surgery will be 3-4 months
Secondary outcomes (3)
Concordance rate of axillary Sentinel Node (SN) identified with BOTH MagTrace and Technetium-99 after neoadjuvant chemotherapy
Cohort 1: Lymph nodes removed that contain BOTH Magtrace and Technetium-99
Measured: Time between injection of magnetic tracer and technetium-99 is between 3-4 months-
Concordance rate of Sentinel Node and non-Sentinel Nodes identified with BOTH magtrace and technetium-99
Cohort 2: Patients with clinically node positive axillary nodes who undergo neoadjuvant chemotherapy. Targeted axillary dissection followed by axillary clearance to be carried out for comparison of concordance rates
Measured: Time between injection of magnetic tracer and technetium-99 is between 3-4 months-
Incidence of serious adverse events (SAEs)
For both cohort 1 and 2: clinically node negative and positive patients respectively
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start1 Oct 2021
- Primary completion28 Oct 2023
- Study completion28 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a feasibility study
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Uppsala University Hospital
- Responsible party
- Principal investigator, Roger Olofsson Bagge, Sahlgrenska University Hospital
- Investigators
- Fedrik Warnberg, MD PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625698
- Sponsor's protocol ID
- SUGBG-2021002
- Acronym
- SENTINEO
- Status last verified
- Jan 2024
- First submitted
- 15 Nov 2022
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fisher CS, Margenthaler JA, Hunt KK, Schwartz T. The Landmark Series: Axillary Management in Breast Cancer. Ann Surg Oncol. 2020 Mar;27(3):724-729. doi: 10.1245/s10434-019-08154-5. Epub 2019 Dec 20.
PubMed 31863417Racz JM, Caudle AS. Sentinel Node Lymph Node Surgery After Neoadjuvant Therapy: Principles and Techniques. Ann Surg Oncol. 2019 Oct;26(10):3040-3045. doi: 10.1245/s10434-019-07591-6. Epub 2019 Jul 24.
PubMed 31342394Samiei S, van Kaathoven BN, Boersma L, Granzier RWY, Siesling S, Engelen SME, de Munck L, van Kuijk SMJ, van der Hulst RRJW, Lobbes MBI, Smidt ML, van Nijnatten TJA. Risk of Positive Sentinel Lymph Node After Neoadjuvant Systemic Therapy in Clinically Node-Negative Breast Cancer: Implications for Postmastectomy Radiation Therapy and Immediate Breast Reconstruction. Ann Surg Oncol. 2019 Nov;26(12):3902-3909. doi: 10.1245/s10434-019-07643-x. Epub 2019 Jul 29.
PubMed 31359276Warnberg F, Stigberg E, Obondo C, Olofsson H, Abdsaleh S, Warnberg M, Karakatsanis A. Long-Term Outcome After Retro-Areolar Versus Peri-Tumoral Injection of Superparamagnetic Iron Oxide Nanoparticles (SPIO) for Sentinel Lymph Node Detection in Breast Cancer Surgery. Ann Surg Oncol. 2019 May;26(5):1247-1253. doi: 10.1245/s10434-019-07239-5. Epub 2019 Mar 4.
PubMed 30830536Karakatsanis A, Hersi AF, Pistiolis L, Olofsson Bagge R, Lykoudis PM, Eriksson S, Warnberg F; SentiNot Trialists Group. Effect of preoperative injection of superparamagnetic iron oxide particles on rates of sentinel lymph node dissection in women undergoing surgery for ductal carcinoma in situ (SentiNot study). Br J Surg. 2019 May;106(6):720-728. doi: 10.1002/bjs.11110. Epub 2019 Mar 6.
PubMed 30839104Brown AS, Hunt KK, Shen J, Huo L, Babiera GV, Ross MI, Meric-Bernstam F, Feig BW, Kuerer HM, Boughey JC, Ching CD, Gilcrease MZ. Histologic changes associated with false-negative sentinel lymph nodes after preoperative chemotherapy in patients with confirmed lymph node-positive breast cancer before treatment. Cancer. 2010 Jun 15;116(12):2878-83. doi: 10.1002/cncr.25066.
PubMed 20564394Greenwood HI, Wong JM, Mukhtar RA, Alvarado MD, Price ER. Feasibility of Magnetic Seeds for Preoperative Localization of Axillary Lymph Nodes in Breast Cancer Treatment. AJR Am J Roentgenol. 2019 Oct;213(4):953-957. doi: 10.2214/AJR.19.21378. Epub 2019 Jun 5.
PubMed 31166765
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Axillary Lymph Node Identification Before Neoadjuvant Chemotherapy Using MagTrace (Superparamagnetic Iron Oxide Nanoparticles, SPIO) and Magseed, in Clinically Node Negative and Node Positive Patients: a Feasibility Study.
- ClinicalTrials.gov ID
- NCT05625698
- Acronym / sponsor ID
- SENTINEO / SUGBG-2021002
- Conditions
- Breast Cancer
- Keywords
- neoadjuvant chemotherapy, sentinel node, axillary clearance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Uppsala University Hospital
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 28 Oct 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 23 Nov 2022 (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.
Breast cancer is one of the commonest types of cancers in females. Treatments include surgery followed by anti-estrogen therapy, radiotherapy and chemotherapy. During breast surgery, the surgeon removes the cancer from the breast and lymph nodes (glands) from the armpit.
Historically, all armpit lymph nodes were surgically removed but this approach is associated long term problems of arm swelling. In more recent times, an increasingly more selective approach is used to treat the armpit nodes. In the presence of cancer spreads in the nodes, an axillary clearance surgery is done otherwise, only the first node(s) also called sentinel node(s) that drain fluids from the cancer, is surgically removed. The identification of nodes using the latter approach is helped by injecting a tracer in the breast and via the lymphatic channels, the tracer is then concentrated in the sentinel nodes.
Over recent years, neoadjuvant (preoperative) chemotherapy is being increasingly used to treat breast cancers. This treatment approach can lead up to a large of number of complete cancer response. This in turn can cause difficulties in locating the breast cancer / armpit nodes during surgery after the chemotherapy.
New developments like superparamagnetic iron oxide nanoparticles (SPIO or MagTrace®) has been used as an alternate liquid tracer to mark sentinel nodes to facilitate armpit surgery. In addition, small magnetic clip called Magseed® has also been developed which can be inserted into the relevant lymph nodes thereby marking their anatomical position to facilitate surgery. Both MagTrace and Magseed can be used to pre-mark the cancer and armpit nodes before the start of neoadjuvant chemotherapy. In theory, premarking armpit nodes using a magnetic approach is associated with better surgical accuracy in the armpit but there is limited supporting data.
Therefore, this study aims to investigate the feasibility of premarking armpit nodes, with or without cancer spread, using magtrace and magseed respectively before patients undergo neoadjuvant chemotherapy.
Detailed description
Breast cancer is one of the commonest types of cancers in females. Treatments include surgery followed by anti-estrogen therapy (tablet form), radiotherapy (radiation) and chemotherapy (intravenous / tablet form). During breast surgery, the surgeon removes the cancer from the breast and lymph nodes (glands) from the armpit.
Historically, all armpit lymph nodes (clearance) were removed irrespective of the stage of armpit disease which can lead to over-treatment and unnecessary long term arm lymphoedema (swelling). However, the modern approach has become more selective. If there are cancer spread in the nodes at diagnosis, a clearance operation is carried out otherwise only the first node(s) that the cancer spreads to, is removed. The latter procedure is called sentinel node biopsy and it is usually done by injecting a radioactive liquid tracer near the breast cancer. The tracer is then drained via the breast lymphatic channels and concentrated in the relevant armpit nodes where it can be detected by using a detector probe during surgery.
In recent years, there are increasing uses of preoperative (neoadjuvant, NACT) chemotherapy in certain breast cancer subtypes with good cancer response. In up to 70% of cases, the treated cancer had disappeared both, in the breast and armpit, after NACT. Consequently, it can be difficult to locate and surgically remove these nodes in the armpits even with the usual injection of tracer after NACT. These difficulties are due to the damage of lymphatic channels in the breast by NACT and become fibrotic. Therefore, the tracer injected after NACT will no longer be drained correctly to mark the correct nodes in the armpit as the lymphatic channels are altered. In turn, this can lead to wrong sentinel nodes being removed from the armpit, which then can cause inaccurate planning for further treatments.
Over recent times, superparamagnetic iron oxide nanoparticles (SPIO or MagTrace®) has been used as an alternate liquid tracer to mark sentinel nodes to facilitate armpit surgery. In addition, small magnetic clip called Magseed® has also been developed. Magseed® can be directly inserted into the relevant lymph nodes thereby marking their anatomical position to facilitate surgery. Both MagTrace and Magseed are longer lasting materials in the body than the radioactive technetium. Therefore, these new techniques give rise to an opportunity to premark the armpit nodes before the damage to lymphatic channels (with MagTrace) and before the cancer in the nodes disappear (with magseed), after NACT. In theory, premarking armpit nodes using a magnetic approach is associated with better surgical accuracy in the armpit but there is limited supporting data.
Therefore, this study aims to investigate the feasibility of injecting MagTrace before NACT and then identify the sentinel node at surgery, three to six months later. The aim is also to investigate if a metastatic lymph node can be marked with Magseed® before NACT and together with MagTrace identify the metastatic node, as well as additional sentinel nodes at surgery, three to six months later.
The overall aim is to facilitate logistics at surgery, finding the right SN and minimize axillary surgery.
OBJECTIVES:
Primary objectives:
- Cohort 1, Node Negative Patients before NACT: To evaluate the SN detection rate with Magtrace® injected before NACT
- Cohort 2, Node Positive Patients before NACT: To evaluate per-operative identification and removal rate of a Magseed clipped metastatic index lymph node
Secondary objectives:
- Node Negative Patients before NACT: To evaluate the concordance of SN detection by Magtrace® injected before NACT and Technetium (Tc99) +/- blue dye (BD) injected after NACT, respectively
- Node Positive Patients before NACT: To evaluate:
- the SN detection rate with Magtrace® injected before NACT
- the concordance of SNs detected by Magtrace® injected before NACT and Tc99 + BD injected after NACT, during targeted axillary dissection (TAD)
- the number of metastatic SNs and metastatic additional lymph nodes from the axillary dissection
ENDPOINTS:
Primary endpoints:
- Cohort 1, SN detection rate
- Cohort 2, Identification rate and removal rate of clipped index metastatic lymph node
Secondary endpoints:
- Cohort 1, Concordance of SNs identified with Magtrace and Tc99 after NACT
- Cohort 2, a) SN detection rate. b) Concordance of SNs identified with MagTrace and Tc99 after NACT. c) Number of metastatic lymph nodes among SNs and additional lymph nodes
- Cohort 1+2, Incidence of serious adverse events (SAEs).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a feasibility study
| Arm | Type | Receives |
|---|---|---|
| MagTrace only | Other | Drug: MagTrace onlyCohort 1: Clinically node negative patients undergoing neoadjuvant chemotherapy. This cN0-group will receive MagTrace injections before start of neoadjuvant chemotherapy followed standard routine technetium-99 injections after neoadjuvant chemotherapy to facilitate surgery. Nodes containing Magtrace will be detected by finding the magnetic signals using the SentiMag probe. No other interventions during chemotherapy treatments |
| MagTrace and Magseed | Other | Combination Product: MagTrace and MagseedCohort 2: Clinically node positive patients undergoing neoadjuvant chemotherapy. This N+ group will receive MagTrace injection in the breast to mark sentinel nodes and Magseed will be inserted into the index metastatic node before the start of neoadjuatnt chemotherapy followed by standard routine technetium-99 injections after neoadjuvant chemotherapy to facilitate surgery. Nodes containing Magtrace / Magseed will be detected by finding the magnetic signals using the SentiMag probe. No other interventions during chemotherapy treatments |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A patient meeting the following criteria is eligible for participation in the study:
- Patients 18 years of age or older
- Patients with breast cancer planned to undergo preoperative chemotherapy (NACT) with a) planned sentinel lymph node biopsy (SNB) or b) axillary lymph node dissection, in conjunction with the beast surgery after NACT
Key exclusion criteria (7 listed)
- Intolerance / hypersensitivity to iron or dextran compounds or SPIO.
- Patients who are required to undergo MR to evaluate tumour response
- Pregnancy or breast feeding
- Patients with an iron overload disease.
- Patient deprived of liberty or under guardianship.
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 |
|---|---|---|
| MagTrace onlyAlso: SPIOsee information in arm descriptions | Drug | MagTrace only |
| MagTrace and MagseedAlso: SPIOsee information in arm descriptions | Combination product | MagTrace and Magseed |
Primary outcome
Detection rate of axillary sentinel node after neoadjuvant chemotherapy
Time frame: Time between injection of magnetic tracer and technetium-99 is between 3-4 months-
Cohort 1: Patients with clinically node negative axillary nodes who undergo neoadjuatnt chemotherapy- Injected with Magtrace (magnetic non particles) near the breast cancer. Detection rate of SN using magtrace to be compared with there rate using the standard comparator Technetium-99
Detection rate of pre-marked metastatic axillary node(s) with magseed after neoadjuvant chemotherapy
Time frame: Time between magseed insertion of magnetic tracer and surgery will be 3-4 months
Cohort 2: Patients with clinically node positive axillary nodes who undergo neoadjuatnt chemotherapy- Injected with Magtrace (magnetic non particles) near the breast cancer. Detection rate of SN using magtrace to be compared with there rate using the standard comparator Technetium-99
3 secondary outcomes
Concordance rate of axillary Sentinel Node (SN) identified with BOTH MagTrace and Technetium-99 after neoadjuvant chemotherapy
Time frame: Time between injection of magnetic tracer and technetium-99 is between 3-4 months-
Concordance rate of Sentinel Node and non-Sentinel Nodes identified with BOTH magtrace and technetium-99
Time frame: Time between injection of magnetic tracer and technetium-99 is between 3-4 months-
Incidence of serious adverse events (SAEs)
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Background: PubMed 31863417Fisher CS, Margenthaler JA, Hunt KK, Schwartz T. The Landmark Series: Axillary Management in Breast Cancer. Ann Surg Oncol. 2020 Mar;27(3):724-729. doi: 10.1245/s10434-019-08154-5. Epub 2019 Dec 20.
- Background: PubMed 31342394Racz JM, Caudle AS. Sentinel Node Lymph Node Surgery After Neoadjuvant Therapy: Principles and Techniques. Ann Surg Oncol. 2019 Oct;26(10):3040-3045. doi: 10.1245/s10434-019-07591-6. Epub 2019 Jul 24.
- Background: PubMed 31359276Samiei S, van Kaathoven BN, Boersma L, Granzier RWY, Siesling S, Engelen SME, de Munck L, van Kuijk SMJ, van der Hulst RRJW, Lobbes MBI, Smidt ML, van Nijnatten TJA. Risk of Positive Sentinel Lymph Node After Neoadjuvant Systemic Therapy in Clinically Node-Negative Breast Cancer: Implications for Postmastectomy Radiation Therapy and Immediate Breast Reconstruction. Ann Surg Oncol. 2019 Nov;26(12):3902-3909. doi: 10.1245/s10434-019-07643-x. Epub 2019 Jul 29.
- Background: PubMed 30830536Warnberg F, Stigberg E, Obondo C, Olofsson H, Abdsaleh S, Warnberg M, Karakatsanis A. Long-Term Outcome After Retro-Areolar Versus Peri-Tumoral Injection of Superparamagnetic Iron Oxide Nanoparticles (SPIO) for Sentinel Lymph Node Detection in Breast Cancer Surgery. Ann Surg Oncol. 2019 May;26(5):1247-1253. doi: 10.1245/s10434-019-07239-5. Epub 2019 Mar 4.
- Background: PubMed 30839104Karakatsanis A, Hersi AF, Pistiolis L, Olofsson Bagge R, Lykoudis PM, Eriksson S, Warnberg F; SentiNot Trialists Group. Effect of preoperative injection of superparamagnetic iron oxide particles on rates of sentinel lymph node dissection in women undergoing surgery for ductal carcinoma in situ (SentiNot study). Br J Surg. 2019 May;106(6):720-728. doi: 10.1002/bjs.11110. Epub 2019 Mar 6.
- Background: PubMed 20564394Brown AS, Hunt KK, Shen J, Huo L, Babiera GV, Ross MI, Meric-Bernstam F, Feig BW, Kuerer HM, Boughey JC, Ching CD, Gilcrease MZ. Histologic changes associated with false-negative sentinel lymph nodes after preoperative chemotherapy in patients with confirmed lymph node-positive breast cancer before treatment. Cancer. 2010 Jun 15;116(12):2878-83. doi: 10.1002/cncr.25066.
- Background: PubMed 31166765Greenwood HI, Wong JM, Mukhtar RA, Alvarado MD, Price ER. Feasibility of Magnetic Seeds for Preoperative Localization of Axillary Lymph Nodes in Breast Cancer Treatment. AJR Am J Roentgenol. 2019 Oct;213(4):953-957. doi: 10.2214/AJR.19.21378. Epub 2019 Jun 5.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Fedrik Warnberg, MD PhD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MagTrace only and MagTrace and Magseed in people with Breast Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
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 7 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: finished, as of the sponsor's last update on 26 Jan 2024. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Detection rate of axillary sentinel node after neoadjuvant chemotherapy (time frame: Time between injection of magnetic tracer and technetium-99 is between 3-4 months-). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05625698, which also lists 7 linked publications.
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 26 Jan 2024.