Axillary Sentinel Lymph Node Detection in Breast Cancers > 2 cm (GAS2PLUS)
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|ClinicalTrials.gov Identifier: NCT00636467|
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : September 26, 2012
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).
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: No name||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||249 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Technique of Axillary Sentinel Lymph Node (SLN) Detection in Breast Cancers > 2 cm|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||September 2011|
Experimental: No label
Injection of Nanocis® or Nanocoll® (Tc-colloid) 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)
Other: No name
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)
- Quality criteria of the SLN detection technique [ Time Frame: 1 month ]
- Total number of sampled SLN per patient [ Time Frame: 1 month ]
- Detection of SLN by means of extra-axillary markings (lymphoscintigraphy) [ Time Frame: 1 month ]
- Histopathological results (SLN) [ Time Frame: 1 month ]
- Histopathological results (dissection) [ Time Frame: 1 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636467
|Principal Investigator:||Hervé MIGNOTTE, MD||Centre Leon Berard, Lyon|