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

NCT ID: NCT01254929

Last Updated: 2020-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

299 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2020-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cancer Bone Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

F-18 PET bone scan

Intervention Type DEVICE

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

Tc-99m bone scan

Intervention Type DEVICE

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

Interventions

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F-18 PET bone scan

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

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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PET Allegro scanner Philips/ADAC Genesys gamma camera

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seattle Nuclear Medicine

OTHER

Sponsor Role lead

Responsible Party

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David Djang

Nuclear medicine physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Djang, MD

Role: PRINCIPAL_INVESTIGATOR

Seattle Nuclear Medicine

Locations

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Seattle Nuclear Medicine

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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CAG00065R

Identifier Type: -

Identifier Source: org_study_id

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