Clinical trial NCT01927939: 18F-FDG PET Metabolic Phenotype in Evaluating Therapeutic Response for Breast Cancer Patients With Bone Metastases.
Official title: The Effectiveness of 18F-FDG PET Metabolic Phenotype in Evaluating Therapeutic Response for Breast Cancer Patients With Bone Metastases.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
18F-FDG PET
Keywords: Breast cancer; bone metastases; 18F-FDG PET; 99mTc bone scintigraphy; therapy response monitoring; prognosis
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-08-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Histological proven breast cancer, with known metastatic bone lesion(s)

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The uptake of 18F-FDG PET.
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Yen Ruoh Fang, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
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