Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Determine and compare sensitivity and specificity of 3 different modalities for the prediction of effectiveness of neoadjuvant chemotherapy

Outcome Description:

Determine and compare sensitivity and specificity of 3 different modalities for the prediction of effectiveness of neoadjuvant chemotherapy

Outcome Time Frame:

during de study

Safety Issue:

Yes

Principal Investigator

Jean-Noël TALBOT, Pr,MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris

Authority:

France: Ministry of Health

Study ID:

P020907

NCT ID:

NCT00236275

Start Date:

May 2004

Completion Date:

December 2007

Related Keywords:

  • Breast Cancer
  • Comparison of imaging modalities
  • predict the effectiveness of neoadjuvant chemotherapy
  • Breast Neoplasms

Name

Location