Breast CancerMagNeoNCT05985551
Delayed SLND for Patients With Breast Cancer Undergoing Primary Systemic Treatment
An observational study of Breast Cancer and Chemotherapy Effect, run by Uppsala University at 1 site in Sweden.
Trial summary
The goal of this study was to assess the feasibility of SLND by superparamagnetic iron oxide nanoparticles (SPIO) in patients with early breast cancer planned for primary systemic therapy (PST) and whether this is affected by the timeframe of SPIO administration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Chemotherapy Effect, Sentinel Lymph Node
- What is being tested?
- SLND or TAD by the magnetic technique (SPIO)
- How many people
- 114 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2020to 30 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that fulfilled all eligibility criteria as listed above
Who may be able to join
- Adult patients with non-metastatic primary breast cancer and cN0/cN1 axilla, as defined by clinical examination and axillary ultrasound (with fine needle aspiration or core biopsy verification of metastasis) intended for PST (chemotherapy, targeted treatment or endocrine therapy) with a curative intention at diagnosis,
Who cannot join
- Distant metastases at diagnosis
- Inflammatory breast cancer
- Tumor progression during PST for cN1 patients
- ycN1 after completion of PST
- surgery before the completion of PST for any reason (PST adverse effects, patient preference)
- cN1-to-ycN0 patients that opted for ALND
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study on the Timeframe of Superparamagnetic Iron Oxide Nanoparticles Administration in Patients Receiving Primary Systemic Therapy for Early Breast Cancer
The goal of this study was to assess the feasibility of SLND by superparamagnetic iron oxide nanoparticles (SPIO) in patients with early breast cancer planned for primary systemic therapy (PST) and whether this is affected by the timeframe of SPIO administration.
For this, patients with cN0/1 disease planned for PST received radioisotope as per routine on the day of surgery or the day before, and SPIO was injected in an extended timeframe, at any point from the day of surgery to before the induction of PST.
Read more
The main points to investigate are:
- If the SPIO detection rate and concordance to the radiosotope are affected by time of SPIO injection
- If the nodal yield and the accuracy of the procedure are affected
Read the detailed description
Superparamagnetic Iron Nanoparticles (SPIO) have shown comparable performance to the standard of Radioisotope (RI) +/- blue dye (BD) for Sentinel Lymph Node Detection in breast cancer, with the advantage of clinical convenience due to easier accessibility, disposal and injection days before surgery.
More interestingly, SPIO provides the possibility for delayed SLND in the setting of a preoperative diagnosis of DCIS, enabling SLN detection weeks after breast surgery, only when specimen pathology has demonstrated invasive cancer, as shown in the SentiNot study. The role of SPIO for SLND in the setting of primary systemic therapy (PST) has not been extensively investigated, while the timeframe from SPIO administration to successful SLN detection in a similar fashion to SentiNot, but in the setting of PST has yet to been defined.
Current evidence suggest that RI-based SLN detection is the accepted standard following PST, with RI-based dual mapping specifically recommended in cN+-to-ycN0 patients, when SLND or targeted axillary dissection (TAD) are performed, as the number of SLNs retrieved has been inversely linked to the false negative rate of the procedure.
Apart from the logistic benefits of SPIO administration prior to PST, an aspect of potential interest is the ability to map the axilla, before the fibrotic changes induced by chemotherapy and lymphatic remodelling occur, that are a concern, especially in the node-positive patients at presentation.
However, in this case, it is imperative to investigate that SPIO remains detectable after a prolonged period of administration and that it does not migrate to higher nodal echelons. While preliminary data suggested feasibility, the aim of this dedicated study was to investigate the width of timeframe of SPIO administration in patients undergoing PST and how SPIO-based detection and concordance to the RI are affected.
In this study, patients scheduled for SLND or TAD after surgery will undergo the procedure with RI as the standard of care and will moreover receive SPIO. The administration of SPIO will take place either on the preoperative period but after the completion of PST, or before the induction of PST. The reason for this is to create a wide time-frame to allow for conclusion with regards to whether the mapping of the axilla prior PST by SPIO is a feasible technique that will then be addressed in a dedicated trial.
- Conditions
- Breast Cancer, Chemotherapy Effect, Sentinel Lymph Node
- Being tested
- SLND or TAD by the magnetic technique (SPIO)
- Keywords
- Neoadjuvant therapy, Breast Cancer, Superparamagnetic Iron oxide nanoparticles, SLND, Targeted axillary Dissection, Delayed SLND
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLND or TAD by the magnetic technique (SPIO)Other
All patients will receive Radioisotope according to standard of care. They will also receive SPIO in a timeframe of clinical convenience, depending on whether primary response is planned by means of MRI. For patients that are ycN0, SLND or TAD will be performed. For those that convert from cN1 to ycN0, the index lymph node will be marked with a paramagnetic marker. Axillary surgery will be undertaken with the magnetic technique and each retrieved lymph node will be controlled for radiation. Upon the completion of the procedure, a background control will be performed with the radioactive signal as guide, to ensure standard of care best practice. Any palpable lymph nodes that are not sentinels with either tracer may be removed at surgeon discretion but will be reported seperately.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between concordance (isotope and SPIO) and timepoint of SPIO administration to surgery
This endpoint is necessary in ensuring that prolonged SPIO administration does not result in the retrieval of "false" SLNs, in the case that SPIO migrates to higher nodal echelons. As the radioisotope is the current standard of care, the concordance of SPIO to the radioisotope and its correlation with time of SPIO adminstration is the appropriate surrogate endpoint.
Measured: At surgery
Detection rate
The successful retrieval of at least one SLN detected by each tracer (SPIO or radioisotope) separately.
Measured: At surgery
Concordance
The rate (patients with at least one SLN detected with both tracers/patients with at least one SLN detected with the radioisotope)
Measured: At surgery
Secondary outcomes (2)
Nodal yield
The median number of SLNs retrieved with each tracer
Measured: At surgery
Nodal concordance
The rate (SLNs detected by both tracers/SLNs detected by the radioisotope)
Measured: At surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Jan 2020
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2027 (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 Uppsala UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital
- Responsible party
- Principal investigator, Andreas Karakatsanis, Uppsala University
- Investigators
- Andreas U Karakatsanis, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985551
- Sponsor's protocol ID
- UUBreast03
- Acronym
- MagNeo
- Status last verified
- May 2024
- First submitted
- 2 Aug 2023
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Patients have not been consented for IPD and separate consent should be sought for this. For any interest, contact andreas.karakatsanis@uu.se
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study on the Timeframe of Superparamagnetic Iron Oxide Nanoparticles Administration in Patients Receiving Primary Systemic Therapy for Early Breast Cancer
- ClinicalTrials.gov ID
- NCT05985551
- Acronym / sponsor ID
- MagNeo / UUBreast03
- Conditions
- Breast Cancer, Chemotherapy Effect, Sentinel Lymph Node
- Keywords
- Neoadjuvant therapy, Breast Cancer, Superparamagnetic Iron oxide nanoparticles, SLND, Targeted axillary Dissection, Delayed SLND
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala University Hospital
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 14 Aug 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 goal of this study was to assess the feasibility of SLND by superparamagnetic iron oxide nanoparticles (SPIO) in patients with early breast cancer planned for primary systemic therapy (PST) and whether this is affected by the timeframe of SPIO administration.
For this, patients with cN0/1 disease planned for PST received radioisotope as per routine on the day of surgery or the day before, and SPIO was injected in an extended timeframe, at any point from the day of surgery to before the induction of PST.
The main points to investigate are:
- If the SPIO detection rate and concordance to the radiosotope are affected by time of SPIO injection
- If the nodal yield and the accuracy of the procedure are affected
Detailed description
Superparamagnetic Iron Nanoparticles (SPIO) have shown comparable performance to the standard of Radioisotope (RI) +/- blue dye (BD) for Sentinel Lymph Node Detection in breast cancer, with the advantage of clinical convenience due to easier accessibility, disposal and injection days before surgery.
More interestingly, SPIO provides the possibility for delayed SLND in the setting of a preoperative diagnosis of DCIS, enabling SLN detection weeks after breast surgery, only when specimen pathology has demonstrated invasive cancer, as shown in the SentiNot study. The role of SPIO for SLND in the setting of primary systemic therapy (PST) has not been extensively investigated, while the timeframe from SPIO administration to successful SLN detection in a similar fashion to SentiNot, but in the setting of PST has yet to been defined.
Current evidence suggest that RI-based SLN detection is the accepted standard following PST, with RI-based dual mapping specifically recommended in cN+-to-ycN0 patients, when SLND or targeted axillary dissection (TAD) are performed, as the number of SLNs retrieved has been inversely linked to the false negative rate of the procedure.
Apart from the logistic benefits of SPIO administration prior to PST, an aspect of potential interest is the ability to map the axilla, before the fibrotic changes induced by chemotherapy and lymphatic remodelling occur, that are a concern, especially in the node-positive patients at presentation.
However, in this case, it is imperative to investigate that SPIO remains detectable after a prolonged period of administration and that it does not migrate to higher nodal echelons. While preliminary data suggested feasibility, the aim of this dedicated study was to investigate the width of timeframe of SPIO administration in patients undergoing PST and how SPIO-based detection and concordance to the RI are affected.
In this study, patients scheduled for SLND or TAD after surgery will undergo the procedure with RI as the standard of care and will moreover receive SPIO. The administration of SPIO will take place either on the preoperative period but after the completion of PST, or before the induction of PST. The reason for this is to create a wide time-frame to allow for conclusion with regards to whether the mapping of the axilla prior PST by SPIO is a feasible technique that will then be addressed in a dedicated trial.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that fulfilled all eligibility criteria as listed above
Key inclusion criteria (1 listed)
- Adult patients with non-metastatic primary breast cancer and cN0/cN1 axilla, as defined by clinical examination and axillary ultrasound (with fine needle aspiration or core biopsy verification of metastasis) intended for PST (chemotherapy, targeted treatment or endocrine therapy) with a curative intention at diagnosis,
Key exclusion criteria (6 listed)
- Distant metastases at diagnosis
- Inflammatory breast cancer
- Tumor progression during PST for cN1 patients
- ycN1 after completion of PST
- surgery before the completion of PST for any reason (PST adverse effects, patient preference)
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 |
|---|---|---|
| SLND or TAD by the magnetic technique (SPIO)All patients will receive Radioisotope according to standard of care. They will also receive SPIO in a timeframe of clinical convenience, depending on whether primary response is planned by means of MRI. For patients that are ycN0, SLND or TAD will be performed. For those that convert from cN1 to ycN0, the index lymph node will be marked with a paramagnetic marker. Axillary surgery will be undertaken with the magnetic technique and each retrieved lymph node will be controlled for radiation. Upon the completion of the procedure, a background control will be performed with the radioactive signal as guide, to ensure standard of care best practice. Any palpable lymph nodes that are not sentinels with either tracer may be removed at surgeon discretion but will be reported seperately. | Other | – |
Primary outcome
Correlation between concordance (isotope and SPIO) and timepoint of SPIO administration to surgery
Time frame: At surgery
This endpoint is necessary in ensuring that prolonged SPIO administration does not result in the retrieval of "false" SLNs, in the case that SPIO migrates to higher nodal echelons. As the radioisotope is the current standard of care, the concordance of SPIO to the radioisotope and its correlation with time of SPIO adminstration is the appropriate surrogate endpoint.
Detection rate
Time frame: At surgery
The successful retrieval of at least one SLN detected by each tracer (SPIO or radioisotope) separately.
Concordance
Time frame: At surgery
The rate (patients with at least one SLN detected with both tracers/patients with at least one SLN detected with the radioisotope)
2 secondary outcomes
Nodal yield
Time frame: At surgery
Nodal concordance
Time frame: At surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Individual participant dataSharing planned: No. Patients have not been consented for IPD and separate consent should be sought for this. For any interest, contact andreas.karakatsanis@uu.se
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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.
Andreas U Karakatsanis, MD, PhD principal investigator
Uppsala University
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 and Chemotherapy Effect, run by Uppsala University 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 1 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 3 May 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?
This study is still under way. Results are not available in the source record yet.
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?
Correlation between concordance (isotope and SPIO) and timepoint of SPIO administration to surgery (time frame: At surgery). The study lists 3 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 3 May 2024.