PET-CT in the Initial Staging of Breast Cancer and in the Early Assessment of Response to Neoadjuvant Chemotherapy
NCT ID: NCT02599974
Last Updated: 2016-09-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
400 participants
OBSERVATIONAL
2006-01-31
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Stage II and III breast cancer
* Neo-adjuvant chemotherapy
* Baseline PET-CT-scan (ASAINT 1 and 2)
* PET-CT-scans after second cycle of neo-adjuvant chemotherapy (ASAINT 2)
* Tumor biopsy for diagnosis and biological analysis with hormone receptors and Human Epidermal Growth Factor Receptor-2 (HER2) available
* Surgical intervention after completion of neo-adjuvant chemotherapy
* Evaluable pathological response
Exclusion Criteria
* Non controlled diabetes mellitus
* Pregnancy
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Matthieu Resche-Rigon, MD-PHD
Role: STUDY_CHAIR
DRCD APHP Paris
David Groheux, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
APHP, IUH, University Paris Diderot, Paris 7, SPC
Locations
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Hopital siant-Louis
Paris, Paris, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NI 12020 ASAINT
Identifier Type: -
Identifier Source: org_study_id
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