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

NCT00236275 | Completed Phase 3 DMC

• 1 other identifier: P020907
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Keywords

Comparison of imaging modalities; predict the effectiveness of neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

1

EXPERIMENTAL

Fluoro-L-thymidine-(18F)

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

Interventions

Fluoro-L-thymidine-(18F) DRUG

Fluoro-L-thymidine-(18F)

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer scheduled for neoadjuvant chemotherapy followed by surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Pierre and Marie Curie University: collaborator

Study Sites (1)

Hôpital TENON

Paris, 75020, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jean-Noël TALBOT, Pr,MD,PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 11, 2005
• First Posted: October 12, 2005
• Study Start: May 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 2, 2011

Record last verified: 2007-03

Locations

FR (1)