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

September 28, 2016 updated by: Assistance Publique - Hôpitaux de Paris

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75010
        • Recruiting
        • Hopital Siant-louis
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Women with large breast cancer treated with neo-adjuvant chemotherapy regimen.

Description

Inclusion Criteria :

  • Histologically confirmed breast cancer
  • 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 :

  • Other tumor localization
  • Non controlled diabetes mellitus
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of distant metastases (M1 patients at baseline PET)
Time Frame: 2 weeks
Detection of distant metastases by FDG PET-CT
2 weeks
Number of metastatic nodes at baseline PET (axillary and extra-axillary)
Time Frame: 2 weeks
Detection of metastatic axillary and extra-axillary nodes by FDG PET-CT
2 weeks
Standard uptake value on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
Time Frame: 2 weeks
2 weeks
Patients overall survival
Time Frame: 5 years
5 years
event free survival
Time Frame: 5 years
5 years
Patients overall survival
Time Frame: 3 years
3 years
event free survival
Time Frame: 3 years
3 years
Patients overall survival
Time Frame: 2 years
2 years
event free survival
Time Frame: 2 years
2 years
Total lesion glycolysis on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
Time Frame: 2 weeks
2 weeks
Metabolic tumor volume on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
Time Frame: 2 weeks
2 weeks
Tumor heterogeneity determined on the FDG-PET (Fluorodeoxyglucose positron emission tomography)
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: David Groheux, MD-PhD, APHP, IUH, University Paris Diderot, Paris 7, SPC
  • Study Chair: Matthieu Resche-Rigon, MD-PHD, DRCD APHP Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

May 28, 2015

First Submitted That Met QC Criteria

November 6, 2015

First Posted (Estimate)

November 9, 2015

Study Record Updates

Last Update Posted (Estimate)

September 29, 2016

Last Update Submitted That Met QC Criteria

September 28, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI 12020 ASAINT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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