F-18 PET Bone Scans Versus Tc-99m Bone Scans for the Diagnosis of Bone Metastases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Seattle Nuclear Medicine.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Seattle Nuclear Medicine
ClinicalTrials.gov Identifier:
NCT01254929
First received: December 3, 2010
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

The purpose of this study is to compare 18F-Fluoride PET bone scans to traditional 99mTc-MDP bone scan to determine if one is better for diagnosing bone metastases.


Condition Intervention
Cancer
Bone Metastases
Device: F-18 PET bone scan
Device: Tc-99m bone scan

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 18F-Fluoride PET Bone Scans Versus Traditional 99mTc-MDP Gamma Camera Bone Scans for the Diagnosis of Bone Metastases: a Blinded, Prospective Trial

Resource links provided by NLM:


Further study details as provided by Seattle Nuclear Medicine:

Primary Outcome Measures:
  • Accurate identification of bone metastases [ Time Frame: Upon study completion (2-3 years) ] [ Designated as safety issue: No ]
    Individual subjects will be reviewed 6-12 months after their bone scans, utilizing all clinical and imaging data available, to determine diagnostic accuracy of each bone scan.


Secondary Outcome Measures:
  • Change in clinical management [ Time Frame: Upon study completion (2-3 years) ] [ Designated as safety issue: No ]
    We will be sending out clinical questionnaires to the referring physicians, asking if the bone scan results helped and/or changed their clinical management. Cumulative data for each type of bone scan will be compared.

  • Determine if F-18 PET bone scans lead to fewer follow-up imaging studies. [ Time Frame: Upon study completion (2-3 years) ] [ Designated as safety issue: No ]
    The Tc-99m bone scans often give equivocal results that require other imaging studies, such as CT or MRI, for further evaluation. F-18 PET bone scans may give more definitive interpretations, and thus may lead to fewer follow-up studies being recommended/obtained.

  • Quantify any adverse events from either type of scan. [ Time Frame: Upon study completion (2-3 years) ] [ Designated as safety issue: Yes ]
    Any adverse events related to either type of scan will be recorded. Adverse events would be rare.

  • Perform subgroup analyses according to cancer cell type. [ Time Frame: Upon study completion (2-3 years) ] [ Designated as safety issue: No ]
    Both types of bone scans may be more or less accurate depending on the cancer cell type. We will attempt to address that question by performing subgroup analyses.


Estimated Enrollment: 300
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
F-18 PET bone scan group Device: F-18 PET bone scan
Following the intravenous administration of approximately 10 mCi F-18, subjects will undergo an F-18 PET bone scan.
Other Name: PET Allegro scanner
Tc-99m MDP bone scan group Device: Tc-99m bone scan
Following the intravenous administration of approximately 30mCi Tc-99m MDP, subjects will undergo a traditional bone scan on a gamma camera.
Other Name: Philips/ADAC Genesys gamma camera

Detailed Description:

Compare the diagnostic sensitivity, specificity, and accuracy of 18F-Fluoride PET bone scans versus traditional 99mTc-MDP bone scans for detecting bone metastases.

Determine if there is a significant change in clinical management between the two types of scans.

Measure and compare the number of equivocal or uncertain findings that would have caused additional testing, particularly additional imaging studies, to be performed for confirmation when using 18F-Fluoride PET bone scans versus 99mTc-MDP bone scans.

To quantify any adverse events resulting from either scan.

To perform subgroup analyses according to cancer cell type.

  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

Patients who have cancer and have been referred for evaluation for bone metastases.

Criteria

Inclusion Criteria:

  • Patient has cancer
  • Has been referred for evaluation of bone metastases
  • Patient or patient's legal representative can understand and consent to enrollment in the study
  • Must be 18 years or older
  • Can remain still during the scan (approximately one hour)
  • Patient has Medicare

Exclusion Criteria:

  • Patient does not have Medicare
  • Under the age of 18
  • Cannot lie still for the necessary time
  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: NCT01254929

Contacts
Contact: David Djang, MD 206 386 6900 davidswdjang@gmail.com
Contact: Victoria Benvegnu 206 386 6900 victoria@seattlenucmed.com

Locations
United States, Washington
Seattle Nuclear Medicine Recruiting
Seattle, Washington, United States, 98104
Contact: David Djang, MD    206-386-6900    davidswdjang@gmail.com   
Principal Investigator: David Djang, MD         
Sub-Investigator: David Haseley, MD         
Sub-Investigator: Andrew Quon, MD         
Sponsors and Collaborators
Seattle Nuclear Medicine
Investigators
Principal Investigator: David Djang, MD Seattle Nuclear Medicine
  More Information

No publications provided

Responsible Party: David Djang, MD, Seattle Nuclear Medicine
ClinicalTrials.gov Identifier: NCT01254929     History of Changes
Other Study ID Numbers: CAG00065R
Study First Received: December 3, 2010
Last Updated: July 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Seattle Nuclear Medicine:
Cancer
Bone metastases

Additional relevant MeSH terms:
Bone Marrow Diseases
Bone Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Diseases
Hematologic Diseases
Musculoskeletal Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014