search
Back to results

PET and MRI in the Follow-up of Neoadjuvant Chemotherapy of Breast Cancer

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Fluoro-L-thymidine-(18F)
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Comparison of imaging modalities, predict the effectiveness of neoadjuvant chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Breast cancer scheduled for neoadjuvant chemotherapy followed by surgery Exclusion criteria: Indicated chemotherapy without that a curative tumorectomies is foreseen(planned) Patient presenting an evolutionary infectious or inflammatory pathology, including an inflammatory breast cancer, being able to be source(spring) of false-positive results(profits) in TEP-FDG Patient in the course of radiotherapy or of chemotherapy or operated at the level of the thorax in 4 weeks preceding the date foreseen(planned) by the examination TEP (pose(installation) of implantable room(chamber) excludes) Diabetic waits Patient already includes in the other protocols of search(research) for Nuclear Medicine or for imaging using ionization radiations Patient not having given her lit(enlightened) assent Wait among which the surveillance TEP or the MRI during the chemotherapy will be impossible (that is by geographical or professional imperative, or if contraindication in the MRI, ex: port(bearing) of a pacemaker, cochlear magnetic implants, metal foreign bodies cf protocol) Of less than 18 years old or pregnant patient. Breast cancer stage(stadium) IV Biopsy on the already realized mammary tumor, for the period(delay) lower than 15 j. In case of alcoholic poisoning or of antecedents of reaction to the injection of ethanol: not inclusion to be discussed.

Sites / Locations

  • Hôpital TENON

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Fluoro-L-thymidine-(18F)

Outcomes

Primary Outcome Measures

Determine and compare sensitivity and specificity of 3 different modalities for the prediction of effectiveness of neoadjuvant chemotherapy
Determine and compare sensitivity and specificity of 3 different modalities for the prediction of effectiveness of neoadjuvant chemotherapy

Secondary Outcome Measures

Full Information

First Posted
October 11, 2005
Last Updated
April 29, 2011
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Pierre and Marie Curie University
search

1. Study Identification

Unique Protocol Identification Number
NCT00236275
Brief Title
PET and MRI in the Follow-up of Neoadjuvant Chemotherapy of Breast Cancer
Official Title
PET and MRI in the Follow-up of Neoadjuvant Chemotherapy of Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Pierre and Marie Curie University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Predict and follow thanks to imaging the response to neoadjuvant chemotherapy in locally advanced breast carcinoma. Hypothesis : FLT-(18F)PET will be a predictor superior to both FDG-(18F) PET and MRI
Detailed Description
PET/CT with FDG-(18F) and FLT-(18F) and MRI are performed at the initial staging, 3 times during sequential adjuvant chemotherapy and prior to surgery, aiming to find the most efficient modality to predict the response to neoadjuvant chemotherapy of the primary breast cancer and its possible lymph node metastases. Post-surgical histology and a 6 month follow-up (to detect occult metastases) will constitute the standard of truth for determination and comparison of diagnostic performances.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Comparison of imaging modalities, predict the effectiveness of neoadjuvant chemotherapy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Fluoro-L-thymidine-(18F)
Intervention Type
Drug
Intervention Name(s)
Fluoro-L-thymidine-(18F)
Intervention Description
Fluoro-L-thymidine-(18F)
Primary Outcome Measure Information:
Title
Determine and compare sensitivity and specificity of 3 different modalities for the prediction of effectiveness of neoadjuvant chemotherapy
Description
Determine and compare sensitivity and specificity of 3 different modalities for the prediction of effectiveness of neoadjuvant chemotherapy
Time Frame
during de study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Breast cancer scheduled for neoadjuvant chemotherapy followed by surgery Exclusion criteria: Indicated chemotherapy without that a curative tumorectomies is foreseen(planned) Patient presenting an evolutionary infectious or inflammatory pathology, including an inflammatory breast cancer, being able to be source(spring) of false-positive results(profits) in TEP-FDG Patient in the course of radiotherapy or of chemotherapy or operated at the level of the thorax in 4 weeks preceding the date foreseen(planned) by the examination TEP (pose(installation) of implantable room(chamber) excludes) Diabetic waits Patient already includes in the other protocols of search(research) for Nuclear Medicine or for imaging using ionization radiations Patient not having given her lit(enlightened) assent Wait among which the surveillance TEP or the MRI during the chemotherapy will be impossible (that is by geographical or professional imperative, or if contraindication in the MRI, ex: port(bearing) of a pacemaker, cochlear magnetic implants, metal foreign bodies cf protocol) Of less than 18 years old or pregnant patient. Breast cancer stage(stadium) IV Biopsy on the already realized mammary tumor, for the period(delay) lower than 15 j. In case of alcoholic poisoning or of antecedents of reaction to the injection of ethanol: not inclusion to be discussed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Noël TALBOT, Pr,MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital TENON
City
Paris
ZIP/Postal Code
75020
Country
France

12. IPD Sharing Statement

Learn more about this trial

PET and MRI in the Follow-up of Neoadjuvant Chemotherapy of Breast Cancer

We'll reach out to this number within 24 hrs