PET-CT in the Initial Staging of Breast Cancer and in the Early Assessment of Response to Neoadjuvant Chemotherapy

• Conditions: Positron-Emission Tomography; Breast Cancer

• Registration Number: NCT02599974
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The two main objectives of this prospective study are:

* to identify those patients for whom pre-treatment FDG (Fluorodeoxyglucose) PET (positron emission tomography) CT-scan (Computed tomography scan) provides useful information for the treatment of breast cancer (ASAINT 1),

* to improve FDG PET-CT-scan imaging criteria for assessing response to neoadjuvant therapy early, in M0-patients (ASAINT 2).

The secondary objective is to better understand the interactions between the imaging parameters of FDG PET-CT-scan and biological and histological features of breast cancer .

This is a non-interventional study. Two PET-CT-scans are performed, one before starting treatment, and the other after 2 cycles of neoadjuvant chemotherapy. The two PET-CT-scans are prescribed by oncologists from the center of breast diseases Unit at St. Louis hospital, in Paris, France. Oncologists provide clear information to the patients on the purpose of the examination. The examinations are performed in the nuclear medicine department at St. Louis hospital. PET-CT-scans data, tumor characteristics, results of other imaging and biological tests, results of surgery and patient's follow-up are summarized in a "de-identified" file. This file has been declared to the National Commission on Informatics and Liberties (CNIL). The data in this file are established prospectively and secondary analyzed to assess the precise role of PET-CT-scans in the initial staging of breast cancer and to determine the optimal PET-CT-scans criteria to evaluate response to neoadjuvant treatment early.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2015-05-28
• Study First Submitted QC: 2015-11-06
• Study First Posted: 2015-11-09
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-28
• Last Update Posted: 2016-09-29
• Primary Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pathological complete response in M0 patients at baseline PET (stage II-III)	18 weeks	Absence of residual cancer cells in the primary breast tumor and in axillary lymph nodes

Secondary Outcome Measures

Name	Time	Method
event free survival	2 years
Total lesion glycolysis on the FDG-PET (Fluorodeoxyglucose positron emission tomography)	2 weeks
Metabolic tumor volume on the FDG-PET (Fluorodeoxyglucose positron emission tomography)	2 weeks
Standard uptake value on the FDG-PET (Fluorodeoxyglucose positron emission tomography)	2 weeks
Number of distant metastases (M1 patients at baseline PET)	2 weeks	Detection of distant metastases by FDG PET-CT
Number of metastatic nodes at baseline PET (axillary and extra-axillary)	2 weeks	Detection of metastatic axillary and extra-axillary nodes by FDG PET-CT
Patients overall survival	2 years
Tumor heterogeneity determined on the FDG-PET (Fluorodeoxyglucose positron emission tomography)	2 weeks

Trial Locations

Locations (1)

Hopital siant-Louis; 🇫🇷 Paris, France