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New treatment option for Breast Cancer
Official title Finding Sentinel Lymph Nodes During Mastectomy Using Indocyanine Green (INIGMA Study)
ClinicalTrials.gov ID: NCT07362485
What this study is testing
- What it's testing
- This pilot study evaluates the diagnostic value of indocyanine green (ICG) fluorescence for sentinel lymph node biopsy (SLNB) performed through the mastectomy incision in breast cancer patients. Women with clinically node-negative, invasive T1-T3 breast cancer undergoing mastectomy with SLNB at St.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Clinically node-negative, DCIS, invasive T1- T3 breast cancer confirmed by biopsy.
- Preoperative axillary ultrasound to confirm clinical node-negative status.
- Indication (or preference) for mastectomy and simultaneous SLN procedure.
- Written informed consent according to ICH/GCP and national regulations.
You likely can't join if
- Patients \< 18 years old
- Breast conserving surgery
- Direct reconstruction (with autologous tissue or implant)
- Known allergy for indocyanine green (ICG) or radioisotope technetium (99mTc), intravenous contrast or iodine
- Other concurrent solid tumour
- Hyperthyroidism or thyroid cancer
See the full eligibility criteria
- Clinically node-negative, DCIS, invasive T1- T3 breast cancer confirmed by biopsy.
- Preoperative axillary ultrasound to confirm clinical node-negative status.
- Indication (or preference) for mastectomy and simultaneous SLN procedure.
- Written informed consent according to ICH/GCP and national regulations.
- Patients \< 18 years old
- Breast conserving surgery
- Direct reconstruction (with autologous tissue or implant)
- Known allergy for indocyanine green (ICG) or radioisotope technetium (99mTc), intravenous contrast or iodine
- Other concurrent solid tumour
- Hyperthyroidism or thyroid cancer
- Pregnancy or breast feeding
- Psychological, familial, sociological or geographical factors that could potentially hamper compliance with the study protocol
The study team makes the final eligibility decision.
Where it's taking place
- Zwolle, Overijssel, Netherlands
- Utrecht, Utrecht, Netherlands
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zwolle, Overijssel, Netherlands; Utrecht, Utrecht, Netherlands. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.