RecruitingNot ApplicableNCT07362485

Finding Sentinel Lymph Nodes During Mastectomy Using Indocyanine Green (INIGMA Study)

Indocyanine Green Guided Identification of Sentinel Lymph Nodes Via Mastectomy Incision in Breast Cancer Patients (INIGMA Study)

Sponsor

Isabelle Henskens

Enrollment

90 participants

Start Date

Aug 22, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Mastectomy Sentinel Lymph Node Biopsy (SLNB)Sentinel Lymph Node Detection Sentinel Lymph Node Lymphatic Metastasis Fluorescence Imaging Indocyanine Green (ICG)Radioisotopes Lymph Node Mapping

Summary

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. Antonius or Isala Hospital will be included. All patients receive standard 99mTc injection preoperatively, followed by 5 mg (2mL) ICG injection after anesthesia. The axilla will be explored for fluorescent lymph nodes via the mastectomy incision, avoiding a separate axillary incision. Primary outcome: ICG detection rate for SLN identification via the mastectomy incision. Secondary outcomes: Comparison with 99mTc detection, number of nodes identified, concordance between methods, pathology differences, detection time, and complications. ICG is safe, non-ionizing, and causes no extra discomfort or visits. Risks and burden are minimal.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a dye called indocyanine green (ICG) to help surgeons find and remove sentinel lymph nodes — the first nodes where breast cancer might spread — during a mastectomy. The goal is to find out if this technique works as reliably as the current standard method. **You may be eligible if...** - You have been diagnosed with early-stage breast cancer (DCIS or invasive T1–T3) with no cancer detected in the lymph nodes on imaging - You are having a mastectomy with a simultaneous lymph node procedure - You are 18 years or older **You may NOT be eligible if...** - You are having breast-conserving surgery (lumpectomy) - You have a known allergy to ICG dye, radioactive technetium, iodine, or IV contrast - You have another active solid tumor - You have hyperthyroidism or thyroid cancer - You are pregnant or breastfeeding - You are having immediate breast reconstruction at the same time Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERIndocyanine green (ICG)-fluorescence guided sentinel lymph node biopsy

ICG-fluorescence is used as the primary tracer to identify SLNs during SLNB in breast cancer surgery. The standard 99mTc-nanocolloid method is used as a control to verify the sentinel lymph nodes identified by ICG. Surgeons are blinded to preoperative lymphoscintigraphy results. After general anesthesia, 5 mg (2 mL of 2.5 mg/mL solutio) of ICG is injected sub-/intracutaneous periareolarly. ICG-fluorescence is detected using near-infrared imaging. SLNB via mastectomy incision is performed. The most fluorescent lymph node is excised first, followed by (maximal 2) additional fluorescent nodes. The excised nodes are tested for 99mTc-activity using a gamma probe. The axilla is then checked with the gamma probe and and palpation for any remaining nodes, which are excised if their radiation count exceeds 10% of the hottest node. All excised lymph nodes are sent for pathological examination to determine the presence of cancer cells. After surgery, the lymphoscintigraphy results are announced.

Locations(2)

Isala

Zwolle, Overijssel, Netherlands

St. Antonius Ziekenhuis

Utrecht, Utrecht, Netherlands

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07362485

Related Trials

Genomic Services Research Program

NCT025959571 location

Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors

NCT052833304 locations

A Synthetic Lethality-Focused Algorithm to Identify Therapeutic Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast)

NCT070671381 location

Social and Environmental Determinants of Breast Cancer Survivorship: the Black Breast Cancer Survivor's Intervention (BBCSI)

NCT068852031 location

A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

NCT06103864316 locations