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

NCT01254929 | Completed

• 1 other identifier: CAG00065R
• Study Type: observational
• Target: 299
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Bone Metastases

Keywords

Cancer; Bone metastases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in clinical management

  Upon study completion (2-3 years)

• Determine if F-18 PET bone scans lead to fewer follow-up imaging studies.

  Upon study completion (2-3 years)

• Quantify any adverse events from either type of scan.

  Upon study completion (2-3 years)

• Perform subgroup analyses according to cancer cell type.

  Upon study completion (2-3 years)

Study Arms (2)

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

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

Interventions

F-18 PET bone scan DEVICE

Following the intravenous administration of approximately 10 mCi F-18, subjects will undergo an F-18 PET bone scan.

Also known as: PET Allegro scanner

F-18 PET bone scan group

Tc-99m bone scan DEVICE

Following the intravenous administration of approximately 30mCi Tc-99m MDP, subjects will undergo a traditional bone scan on a gamma camera.

Also known as: Philips/ADAC Genesys gamma camera

Tc-99m MDP bone scan group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Seattle Nuclear Medicine: lead

Study Sites (1)

Seattle Nuclear Medicine

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• David Djang, MD

  Seattle Nuclear Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nuclear medicine physician

Study Record Dates

• First Submitted: December 3, 2010
• First Posted: December 7, 2010
• Study Start: December 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2020
• Last Updated: March 19, 2020

Record last verified: 2020-03

Locations

US (1)