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

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:

MedlinePlus related topics: Cancer Nuclear Scans

Drug Information available for: Technetium Tc 99m medronate

U.S. FDA Resources

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

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:

Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplastic Processes
Neoplasms

Pathologic Processes
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013