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

• Conditions: Breast Cancer; 18F-FDG PET

• Registration Number: NCT01927939
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-08-16
• Study First Submitted QC: 2013-08-20
• Study First Posted: 2013-08-23
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-13
• Last Update Posted: 2014-04-15
• Primary Completion: 2014-08
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The uptake of 18F-FDG PET.	2 hours

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan