Status:
TERMINATED
Comparison of Diagnostic Performance of an Algorithm and a High Definition Classical Iterative Algorithm Positron Emission Tomography (PET) to 18Fluoro-deoxy-glucose (18FDG) in the Evaluation of Axillary Lymph Node Invasion of Breast Tumors
Lead Sponsor:
Centre Francois Baclesse
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
The primary endpoint of this study is to show that this algorithm in high definition is superior to the classical algorithm in the diagnosis of lymph node metastases.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Informed consent and signed by the patient
- Age ≥ 18 years
- Breast tumor for which the therapeutic indication for surgery has from the outset: breast surgery (conservative or radical) associated with a conventional axillary dissection
- Proof of infiltrating ductal carcinoma histology
- No known metastasis
- No cons-indication to anesthesia.
- Exclusion criteria:
- History of neoadjuvant therapy
- Patients with invasive lobular carcinoma
- Indication of the use of sentinel node (if invasive carcinoma uni-centric, ≤ 2 cm in diameter, without palpable lymphadenopathy (N0))
- Diabetes is not controlled by conventional treatment (blood glucose\> 1.8 g / l)
- Inability to capital
- Patients who are pregnant or nursing or of childbearing potential and not using adequate contraception
- Persons deprived of their liberty
- Major subject of a measure of legal protection or unable to consent
- Refusal to participate
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01436591
Start Date
March 1 2009
End Date
August 1 2012
Last Update
September 10 2012
Active Locations (1)
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1
Centre François Baclesse
Caen, France, 14076