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

Terminated

• Conditions: Breast Cancer

• Registration Number: NCT01436591
• Lead Sponsor: Centre Francois Baclesse

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2011-09-15
• Study First Submitted QC: 2011-09-16
• Study First Posted: 2011-09-19
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-07
• Last Update Posted: 2012-09-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 63

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 Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance of FDG-PET for the evaluation of nodal status	3 years	Show that the algorithm of high-definition positron emission tomography (PET) to 18Fluoro-deoxy-glucose (18FDG) is greater than a classical algorithm in the diagnosis of lymph node metastases.

Secondary Outcome Measures

Name	Time	Method
Information on lymph node status in patients with breast cancer.	3 years	Show that scintigraphy performed on a FDG positron camera equipped with a reconstruction algorithm for high-definition can provide reliable information on lymph node status in patients with breast cancer and determine the minimum size of lymph node metastatic lesions.

Trial Locations

Locations (1)

Centre François Baclesse; 🇫🇷 Caen, France