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18F-FDG PET Metabolic Phenotype in Evaluating Therapeutic Response for Breast Cancer Patients With Bone Metastases.

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National Taiwan University

Status

Unknown

Conditions

Breast Cancer
18F-FDG PET

Study type

Observational

Funder types

Other

Identifiers

NCT01927939
201207002MIB

Details and patient eligibility

About

This study is to evaluate the effectiveness of 18F-FDG PET in following up of metastastic bone lesions and in predicting outcome for breast cancer patients after therapy.

Primary outcome: Using 18F-FDG uptake to evaluate the metastatic bone status after treatment. The PET results will be compared with the results in Tc-99m MDP bone scintigraphy.

Secondary outcome: Evaluate the relationship between the 18F-FDG uptake of the metastatic bone lesions and (1) breast cancer related tumor marker, (2) patients' survival.

Full description

Background: Although 99mTc MDP bone scintigraphy is a sensitive tool for screening metastatic bone status, it is not a satisfactory imaging modality in evaluating residual disease after therapy. 18F-FDG PET has been an effective imaging tool for many malignancies including breast cancer, not only in diagnosis and staging, but also in monitoring response and following up disease status after therapy.

Purpose: This study is to evaluate the effectiveness of 18F-FDG PET in following up of metastastic bone lesions and in predicting outcome for breast cancer patients after therapy.

Method: Breast cancer patients with bone metastases, age 20-90 year-old, will be included in this study.

Primary outcome: Using 18F-FDG uptake to evaluate the metastatic bone status after treatment. The PET results will be compared with the results in Tc-99m MDP bone scintigraphy.

Secondary outcome: Evaluate the relationship between the 18F-FDG uptake of the metastatic bone lesions and (1) breast cancer related tumor marker, (2) patients' survival.

Enrollment

100 estimated patients

Sex

Female

Ages

20 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Age:20-90 years old
  2. Histological proven breast cancer, with known metastatic bone lesion(s)
  3. written informed consent signed

Exclusion criteria

  1. pregnant or intend to be pregnant
  2. other malignancies known

Trial design

100 participants in 1 patient group

Histological proven breast cancer with bone lesion

Trial contacts and locations

1

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Central trial contact

Yen Ruoh Fang, M.D.,Ph.D.

Data sourced from clinicaltrials.gov

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