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

18F-Fluoride PET Bone Scans Versus Traditional 99mTc-MDP Gamma Camera Bone Scans for the Diagnosis of Bone Metastases: a Blinded, Prospective Trial

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.

Study Overview

• Status: Completed
• Conditions: Cancer; Bone Metastases
• Intervention / Treatment: Device: F-18 PET bone scan; Device: Tc-99m bone scan

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.

• Study Type: Observational
• Enrollment (Actual): 299

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Seattle Nuclear Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
F-18 PET bone scan group; Patients with a diagnosis of cancer and clinical concern for bone metastases. They will undergo an F-18 PET bone scan for diagnostic imaging.	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 Names: PET Allegro scanner
Tc-99m MDP bone scan group; Patients with a diagnosis of cancer and clinical concern for bone metastases. They will undergo a Tc-99m MDP bone scan for diagnostic imaging.	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 Names: Philips/ADAC Genesys gamma camera

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Seattle Nuclear Medicine
• Investigators: Principal Investigator: David Djang, MD, Seattle Nuclear Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2010
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: December 3, 2010
• First Submitted That Met QC Criteria: December 6, 2010
• First Posted (Estimate): December 7, 2010

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Cancer; Bone metastases
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Hematologic Diseases; Musculoskeletal Diseases; Neoplastic Processes; Bone Diseases; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Serotonin Agents; Serotonin Receptor Agonists; Frovatriptan
• Other Study ID Numbers: CAG00065R