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OpenTrials
Completed

NCT Number: NCT00236275

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hôpital TENON

Paris, 75020, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fluoro-L-thymidine-(18F)

Drug

Fluoro-L-thymidine-(18F)

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Pierre and Marie Curie University

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Oct 12, 2005
Registry last updated
May 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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