At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of the Technique of Axillary Sentinel Lymph Node (SLN) Detection in Breast Cancers > 2 cm
In Brief
A Phase 2 clinical trial evaluating No name for Breast Cancer. Completed, enrolled 249 participants across 22 sites.
Detailed Summary
The purpose of this study is to evaluate the quality criteria of the SLN detection technique in breast cancer patients with a tumor size (clinical measurement) greater than 2 centimeters (rate of false negatives, rate of detection). Eligible patients will only be registered (no randomization). The estimated inclusion period is approximately 24 months. The duration of the research is 25 months (24 months for patient inclusion + 1 month for reception of results). The maximum participation duration of each patient is 1 month. The number of patients required in this multicentric and prospective study is 240 (16 participating centers).
Study Details
Timeline
Interventions
Injection of Nanocis® or Nanocoll® on the day before surgery followed by lymphoscintigraphy (long protocol, method n°1) or injection of Nanocis® or Nanocoll® on the morning of the surgery followed by lymphoscintigraphy at least 2h30 later (short protocol, method n° 2)