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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254929
• Other study ID #: CAG00065R
• Status: Completed
• Start date: December 2010
• Est. completion date: March 2020

Study information

• Verified date: March 2020
• Source: Seattle Nuclear Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: March 2020
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Cancer
• Neoplasm Metastasis
• Neoplasms, Second Primary

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Seattle Nuclear Medicine	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Nuclear Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accurate identification of bone metastases	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.	Upon study completion (2-3 years)
Secondary	Change in clinical management	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.	Upon study completion (2-3 years)
Secondary	Determine if F-18 PET bone scans lead to fewer follow-up imaging studies.	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.	Upon study completion (2-3 years)
Secondary	Quantify any adverse events from either type of scan.	Any adverse events related to either type of scan will be recorded. Adverse events would be rare.	Upon study completion (2-3 years)
Secondary	Perform subgroup analyses according to cancer cell type.	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.	Upon study completion (2-3 years)