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Delayed SLND Tracing for Breast Cancer (SENTINOT_2 Trial)
Phase 3
Recruiting
Led By Andreas Karakatsanis, PhD
Research Sponsored by Uppsala University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with a preoperative diagnosis of DCIS with suspicion of micro-invasion on core biopsy
Patients with a mammographic/ultrasound/MRI finding, suspicious for breast cancer (BIRADS 4 or 5) planned for diagnostic excision with breast conserving surgery, with no definitive diagnosis of invasive cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
SENTINOT_2 Trial Summary
This trial is investigating the use of superparamagnetic iron oxide nanoparticles as a tracer for delayed sentinel lymph node dissection in patients where upfront axillary surgery is oncologically deemed unnecessary.
Who is the study for?
This trial is for patients with a pre-diagnosis of ductal cancer in situ (DCIS) or suspicious breast lesions, who are undergoing procedures that might affect future sentinel lymph node detection. It's also open to those planning risk-reducing mastectomies or complex oncoplastic surgeries. Excluded are individuals with iron/dextran/SPIO hypersensitivity, iron overload diseases, pregnant/lactating women, and those deprived of liberty or under guardianship.Check my eligibility
What is being tested?
The study tests the use of superparamagnetic iron oxide nanoparticles as a tracer for delayed sentinel lymph node dissection in breast cancer cases where immediate axillary surgery isn't necessary. If invasive cancer is found after initial surgery, then an operation in the axilla follows.See study design
What are the potential side effects?
Potential side effects may include reactions related to intolerance to SPIO such as allergic reactions or issues due to excess iron from the nanoparticles used during the procedure.
SENTINOT_2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was diagnosed with DCIS and there might be very small invasions.
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I am scheduled for a breast surgery due to a suspicious finding but don't have a confirmed cancer diagnosis.
Select...
I have a high-grade or large pre-cancerous breast lesion and am planning to conserve my breast.
Select...
I have been diagnosed with DCIS and am planning a complex breast surgery.
Select...
I was diagnosed with DCIS and have a noticeable lump or mass effect.
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I am diagnosed with DCIS and planning a mastectomy.
SENTINOT_2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Nodal concordance
d-SLND detection rate
l-SLND detection rate
Secondary outcome measures
Malignancy rate
Nodal Malignancy rate
Per patient concordance
+1 moreOther outcome measures
Breast Specific Health Related Quality of Life (HR-QoL)
Cost effectiveness
Disease free interval
+4 moreSENTINOT_2 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Delayed SLND (SPIO-first arm)Experimental Treatment1 Intervention
All study participants have been injected interstitially with SPIO, 2ml, at the primary operation. Magnetic axillary signal is registered at the end of the procedure but the SLN is not removed. If invasive cancer is found in the specimen, reoperation for SLND with the addition of Tc +/- BD is performed.
At reoperation, SPIO is the "primary" detection tracer.
Group II: Late SLND (RI-first arm)Active Control1 Intervention
All study participants have been injected interstitially with SPIO, 2ml, at the primary operation. Magnetic axillary signal is registered at the end of the procedure but the SLN is not removed. If invasive cancer is found in the specimen, reoperation for SLND with the addition of Tc +/- BD is performed.
At reoperation, Tc is the "primary" detection tracer.
Find a Location
Who is running the clinical trial?
Skane University HospitalOTHER
166 Previous Clinical Trials
85,979 Total Patients Enrolled
Sahlgrenska University Hospital, SwedenOTHER
415 Previous Clinical Trials
297,101 Total Patients Enrolled
6 Trials studying Breast Cancer
1,249 Patients Enrolled for Breast Cancer
Norrlands University HospitalOTHER
10 Previous Clinical Trials
2,378 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was diagnosed with DCIS and there might be very small invasions.I am not under legal supervision or guardianship.I have a condition that causes too much iron in my body.I am scheduled for a breast surgery due to a suspicious finding but don't have a confirmed cancer diagnosis.I was diagnosed with a specific type of non-invasive breast condition before surgery.You are allergic or have a bad reaction to iron, dextran compounds, or SPIO.I have a high-grade or large pre-cancerous breast lesion and am planning to conserve my breast.I have been diagnosed with DCIS and am planning a complex breast surgery.I have been diagnosed with DCIS and am planning a surgery that might affect future lymph node detection.I was diagnosed with DCIS and have a noticeable lump or mass effect.I am planning a preventive breast removal surgery based on my doctor's advice or hospital policy.I am diagnosed with DCIS and planning a mastectomy.
Research Study Groups:
This trial has the following groups:- Group 1: Delayed SLND (SPIO-first arm)
- Group 2: Late SLND (RI-first arm)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What goals does this experiment aim to achieve?
"The primary outcome variable that will be assessed in this study is the l-SLND detection rate, which will be evaluated at a single time point (at operation). Secondary outcome measures include Per patient concordance, Malignancy rate, and Nodal Malignancy rate. Analyses will be performed cumulatively and +/-BD and per type of surgery (BCT or mastectomy)."
Answered by AI
Are there any anticipated risks associated with Delayed SLND?
"Given that this is a phase 3 trial with both efficacy and safety data, our team at Power has rated the safety of Delayed SLND as a 3."
Answered by AI
Are we still recruiting participants for this trial?
"That is correct. The clinical trial, which was posted on March 1st 2020 and updated on March 14th 2022, is still recruiting patients. They are looking for 500 individuals across 1 medical centre."
Answered by AI
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