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Completed

NCT Number: NCT01254929

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

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.

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Key information

Conditions

Cancer Bone Metastases Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seattle Nuclear Medicine

Seattle, Washington, 98104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: PET Allegro scanner

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.

Other names: Philips/ADAC Genesys gamma camera

Primary outcomes

  1. Accurate identification of bone metastases

    Time frame: Upon study completion (2-3 years)

    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 outcomes

  1. Change in clinical management

    Time frame: Upon study completion (2-3 years)

    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.

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

    Time frame: Upon study completion (2-3 years)

    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.

  3. Quantify any adverse events from either type of scan.

    Time frame: Upon study completion (2-3 years)

    Any adverse events related to either type of scan will be recorded. Adverse events would be rare.

  4. Perform subgroup analyses according to cancer cell type.

    Time frame: Upon study completion (2-3 years)

    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.

Sponsors and collaborators

Lead sponsor

Seattle Nuclear Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2020
First posted
Dec 7, 2010
Registry last updated
Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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