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)
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Pathological complete response in M0 patients at baseline PET (stage II-III)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Pathological complete response in M0 patients at baseline PET (stage II-III)
Time Frame: 18 weeks
Absence of residual cancer cells in the primary breast tumor and in axillary lymph nodes
Secondary Outcomes
- 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)
- Number of metastatic nodes at baseline PET (axillary and extra-axillary)(2 weeks)
- Patients overall survival(2 years)
- Tumor heterogeneity determined on the FDG-PET (Fluorodeoxyglucose positron emission tomography)(2 weeks)