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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00236275
First Posted: October 12, 2005
Last Update Posted: May 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pierre and Marie Curie University
Information provided by:
Assistance Publique - Hôpitaux de Paris
  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
Breast Cancer Drug: Fluoro-L-thymidine-(18F) Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PET and MRI in the Follow-up of Neoadjuvant Chemotherapy of Breast Cancer

Resource links provided by NLM:


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 [ Time Frame: during de study ]
    Determine and compare sensitivity and specificity of 3 different modalities for the prediction of effectiveness of neoadjuvant chemotherapy


Enrollment: 60
Study Start Date: May 2004
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Fluoro-L-thymidine-(18F)
Drug: Fluoro-L-thymidine-(18F)
Fluoro-L-thymidine-(18F)

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00236275


Locations
France
Hôpital TENON
Paris, France, 75020
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Pierre and Marie Curie University
Investigators
Principal Investigator: Jean-Noël TALBOT, Pr,MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Zakia IDIR, Department Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00236275     History of Changes
Other Study ID Numbers: P020907
First Submitted: October 11, 2005
First Posted: October 12, 2005
Last Update Posted: May 2, 2011
Last Verified: March 2007

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Comparison of imaging modalities
predict the effectiveness of neoadjuvant chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Telbivudine
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action