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CompletedNCT00236275Updated May 2, 2011

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

A Phase 3 interventional study of Fluoro-L-thymidine-(18F) in Breast Cancer, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-02.

Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Diagnostic

Phase
Phase 3
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
01

Study 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

Read the 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • Comparison of imaging modalities
  • predict the effectiveness of neoadjuvant chemotherapy
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 60 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Breast cancer scheduled for neoadjuvant chemotherapy followed by surgery

Exclusion criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    1

    Fluoro-L-thymidine-(18F)

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

Interventions

  • DrugFluoro-L-thymidine-(18F)

    Fluoro-L-thymidine-(18F)

06

What researchers measure

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

    Time frame: during de study

07

Study locations

1 site
  • Hôpital TENON
    Paris, 75020, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 2, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00236275
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Pierre and Marie Curie University
First posted
Oct 12, 2005
Start date
May 2004
Primary completion
Dec 2007
Completion
Dec 2007
Last update
May 2, 2011

Study contacts

Jean-Noël TALBOT, Pr,MD,PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

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