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

April 13, 2014 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Yen Ruoh Fang, M.D., Ph.D.
          • Phone Number: 65581 886-2-23123456
          • Email: rfyen@ntu.edu.tw
        • Principal Investigator:
          • Yen Ruoh Fang, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Histological proven breast cancer, with known metastatic bone lesion(s)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Histological proven breast cancer with bone lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The uptake of 18F-FDG PET.
Time Frame: 2 hours
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Yen Ruoh Fang, M.D.,Ph.D., National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

August 16, 2013

First Submitted That Met QC Criteria

August 20, 2013

First Posted (Estimate)

August 23, 2013

Study Record Updates

Last Update Posted (Estimate)

April 15, 2014

Last Update Submitted That Met QC Criteria

April 13, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201207002MIB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe