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 (TEP-Sein)

Centre Francois Baclesse

Status: Terminated

Conditions: Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT01436591

TEP-Sein

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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