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Sentinel Node in Endometrial Cancer

NCT04492995 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-09-18

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Judit Pich Martínez

    lead OTHER

Principal Investigators

  • Pilar Paredes, MD · Hospital Clinic of Barcelona

  • Sergi Vidal · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-05
Primary Completion
2023-09-30
Completion
2023-09-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04492995 on ClinicalTrials.gov