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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00236275
• Other study ID #: P020907
• Status: Completed
• Phase: Phase 3
• First received: October 11, 2005
• Last updated: April 29, 2011
• Start date: May 2004
• Est. completion date: December 2007

Study information

• Verified date: March 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Fluoro-L-thymidine-(18F)
Fluoro-L-thymidine-(18F)

Locations

Country	Name	City	State
France	Hôpital TENON	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Pierre and Marie Curie University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	during de study	Yes