Breast Cancer Clinical Trial
Official title:
Role of Fluorodeoxyglucose (FDG) PET-CT in the Initial Staging of Breast Cancer (ASAINT 1) and in the Early Assessment of Response to Neoadjuvant Chemotherapy (ASAINT 2)
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.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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