NCT04492995

Sentinel Node in Endometrial Cancer

Sentinel Node in Endometrial Cancer by Detection of Hybrid ([99mTc] Tc-albumin Nanocoloid-ICG). A Comparative Pilot Study Between the Lymphatic Map Derived From the Cervical Puncture Versus Myometrial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Judit Pich Martínez · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase II, open-label, randomized pilot study. Patients will be randomized (1:1) to receive for sentinel node screening: 1. Radiotracer (RT) via cervical administration and TUMIR 2. Combination of RT with Indocyanine Green (RT + ICG) via cervical administration and TUMIR Patients will be followed up to 1 month after the last administration of radiotracer 70 patients will be included into the study.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml)	The day before the surgery, a new scan (planar and SPECT / CT) will be performed after the injection via TUMIR of the tracer \[99mTc\] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml) or the injection via TUMIR of \[99mTc\] Tc-albumin nanocoloid (6mCi, 8ml). The two lymphatic maps will be compared and the number of sentinel nodes identified in each study and the territories of drainage and the difference between them (in number and territories) will be established. On the day of surgery, a cervical injection of methylene blue will be performed at the start of surgery according to usual methodology (2 ml diluted to 50%). Intraoperative detection of the sentinel nodes will take place by visual inspection, using the gammadetector probe and NIR optics. Sentinel node biopsies will be processed according to the usual processing methodology and analysis for the detection of metastases.
DIAGNOSTIC_TEST	injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml).	The day before the surgery, a new scan (planar and SPECT / CT) will be performed after the injection via TUMIR of the tracer \[99mTc\] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml) or the injection via TUMIR of \[99mTc\] Tc-albumin nanocoloid (6mCi, 8ml). The two lymphatic maps will be compared and the number of sentinel nodes identified in each study and the territories of drainage and the difference between them (in number and territories) will be established. On the day of surgery, a cervical injection of methylene blue will be performed at the start of surgery according to usual methodology (2 ml diluted to 50%). Intraoperative detection of the sentinel nodes will take place by visual inspection, using the gammadetector probe and NIR optics. Sentinel node biopsies will be processed according to the usual processing methodology and analysis for the detection of metastases.

Timeline

• Start date: 2020-10-05
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2020-07-30
• Last updated: 2023-09-18

Locations

1 site across 1 country: Spain