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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01927939

Enrollment

100

Registered

2013-08-23

Start date

2012-10-31

Completion date

2014-08-31

Last updated

2014-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

18F-FDG PET, Breast Cancer

Keywords

Breast cancer; bone metastases; 18F-FDG PET; 99mTc bone scintigraphy; therapy response monitoring; prognosis

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
The uptake of 18F-FDG PET.	2 hours

Countries

Taiwan

Contacts

Primary ContactYen Ruoh Fang, M.D.,Ph.D.

rfyen@ntu.edu.tw886-2-23123456

Outcome results