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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators:	Assistance Publique - Hôpitaux de Paris Université Pierre et Marie Curie, Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00236275

Purpose

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

Condition	Intervention	Phase
Advanced Breast Cancer	Drug: Fluoro-L-thymidine-(18F)	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Thymidine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	PET and MRI in the Follow-up of Neoadjuvant Chemotherapy of Breast Cancer

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	May 2004
Estimated Study Completion Date:	December 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236275

Locations

France
Hôpital TENON
PARIS, France, 75020

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Université Pierre et Marie Curie, Paris

Investigators

Principal Investigator:

Jean-Noël TALBOT, Pr,MD,PhD

Assistance Publique - Hôpitaux de Paris

More Information

Study ID Numbers:	P020907, AOR02072
Study First Received:	October 11, 2005
Last Updated:	March 13, 2007
ClinicalTrials.gov Identifier:	NCT00236275
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Comparison of imaging modalities
predict the effectiveness of neoadjuvant chemotherapy

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009