18F-NaF PET in Detecting Metastatic Bone Lesion for Patients With Cancer.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Far Eastern Memorial Hospital
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00414934
First received: December 21, 2006
Last updated: August 13, 2009
Last verified: August 2009
  Purpose

18F ion is a positron emitting bone radiopharmaceuticals. The skeletal uptake of 18F relies on the exchange of hydroxyl ions in the hydroxyapatit crystal which is an indicator of bone metabolic activity (8). It has good soft tissue clearance and high affinity of to the bone matrix. It is able to perform a highly sensitive whole-body screening for bone metastases using a high resolution PET scanner. Therefore, we conduct a prospective study to evaluate the accuracy and clinical value of 18F PET in staging bone metastases by

  1. Comparing the sensitivity of 18F-NaF PET with that of 99mTc-MDP scintigraphy;
  2. Determining the clinical impact of PET results on subsequent patient management.

Condition
Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Effectiveness of Whole-body 18F-NaF PET in Detecting Metastatic Bone Lesion for Patients With Cancer: A Comparison Study With 99mTc-MDP Bone Scintigraphy.

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 100
Study Start Date: October 2006
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
metastatic bone lesion for patients with cancer

Detailed Description:

Skeletal metastases are the most common cause of morbidity and mortality in patients with malignancy, especially in patients with breast cancer, lung cancer, prostate cancer and head & neck cancer. In patients with lung cancer, bone metastases are present in 20-30% of patient at initial diagnosis (1-2). Accuracy staging bone metastases can lead to modification of following treatment and evaluation of prognosis.

The planar whole-body 99mTc-methylene diphosphonate (MDP) radionuclide bone scintigraphy is the most widely used technique in detecting metastatic bone lesions at present. Abnormal tracer accumulation may occur at any skeletal site with an elevated rate of bone turnover. However, conventional planar bone scintigraphy was reported to be less sensitive than MRI in detecting spinal metastases (3-7).

18F ion is a positron emitting bone radiopharmaceuticals. The skeletal uptake of 18F relies on the exchange of hydroxyl ions in the hydroxyapatit crystal which is an indicator of bone metabolic activity (8). It has good soft tissue clearance and high affinity of to the bone matrix. It is able to perform a highly sensitive whole-body screening for bone metastases using a high resolution PET scanner.

To the best of our knowledge, there are only limited studies evaluating the clinical utilization of 18F-NaF PET for detection of bone metastases (10-12). Therefore, we would like to conduct a prospective study to evaluate the accuracy and clinical value of 18F PET in staging bone metastases by

  1. Comparing the sensitivity of 18F-NaF PET with that of 99mTc-MDP scintigraphy;
  2. Determining the clinical impact of PET results on subsequent patient management.

99mTc-MDP scintigraphy and 18F PET will be performed in 2 weeks for all patients. Interpretation of 99mTc-MDP scintigraphy and 18F PET will be performed following the criteria described by Crasnow et all (13). The accuracy of 99mTc-MDP scintigraphy and 18F PET detection of bone metastases for each patient will be determined by the histopathological results, MRI results, or other clinical evidences afterward.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

metastatic bone lesion for patients with cancer

Criteria

Inclusion Criteria:

  • pathology proofed lung cancer and are referred to perform whole-body bone scintigraphies for staging metastatic bone diseases

Exclusion Criteria:

  • patients whose age are below 18
  • pregnant women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414934

Contacts
Contact: Ruoh-Fang Yen, M.D.,Ph.D. 886-2-23123456 ext 5581 rfyen@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Ruoh-Fang Yen, M.D., Ph.D.    886-2-23123456 ext 5581    rfyen@ha.mc.ntu.edu.tw   
Principal Investigator: Ruoh-Fang Yen, M.D., Ph.D.         
Sponsors and Collaborators
National Taiwan University Hospital
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Ruoh-Fang Yen, M.D.,Ph.D. National Taiwan University Hospital
  More Information

Publications:

Responsible Party: Yen RF, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00414934     History of Changes
Other Study ID Numbers: 941220
Study First Received: December 21, 2006
Last Updated: August 13, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
cancer
bone scan
NaF bone PET

ClinicalTrials.gov processed this record on July 20, 2014