CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 99 enrolled
Drug / intervention
indocyanine green +1 moredrug
Likely dose
indocyanine green 2.5 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02279108
NCT02279108Phase 3Completed

Comparative, Prospective, Randomized Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer

Centre Hospitalier Universitaire de Saint Etienne·interventional·Posted Oct 30, 2014·Updated Apr 9, 2018

In Brief

A Phase 3 clinical trial evaluating indocyanine green and isotope for Breast Neoplasms. Completed, enrolled 99 participants across 1 site.

Detailed Summary

The sentinel node has a fundamental role in the management of early breast cancer. Currently, the double detection of blue and radioisotope is recommended. A radioactive material requires the presence of a nuclear medicine department and the approval of health authorities. In many centers, this technique is not available. The use of blue is easier to implement technique. However, allergic reactions and prolonged breast tattoo led many teams to stop the practice. So in common practice, many center use a single method. However, with a single detection, the risk of false negatives and the identification failure rate increased to a significant extent and the number of sentinel lymph node detected and removed is not enough. Under these conditions, find another method of detection seems crucial. According to the literature, the fluorescence method (ICG) is a technique that seems safe and reliable. The investigators therefore propose a prospective, randomized study to investigate the interest of fluorescence associated with the isotopic method.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 30, 2014
Enrollment StartNov 1, 2014
Primary CompletionMay 1, 2016
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 11.7 years ago

Interventions

indocyanine greendrug

One injection, 2.5 milligrams per patient, intradermal use

isotopedrug

One injection, 20 MBq techntium99, intradermal use