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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
David Djang, Seattle Nuclear Medicine
ClinicalTrials.gov Identifier:
NCT01254929
First received: December 3, 2010
Last updated: November 18, 2014
Last verified: November 2014

December 3, 2010
November 18, 2014
December 2010
February 2014   (final data collection date for primary outcome measure)
Accurate identification of bone metastases [ Time Frame: Upon study completion (2-3 years) ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01254929 on ClinicalTrials.gov Archive Site
  • Change in clinical management [ Time Frame: Upon study completion (2-3 years) ] [ Designated as safety issue: No ]
    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.
  • Determine if F-18 PET bone scans lead to fewer follow-up imaging studies. [ Time Frame: Upon study completion (2-3 years) ] [ Designated as safety issue: No ]
    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.
  • Quantify any adverse events from either type of scan. [ Time Frame: Upon study completion (2-3 years) ] [ Designated as safety issue: Yes ]
    Any adverse events related to either type of scan will be recorded. Adverse events would be rare.
  • Perform subgroup analyses according to cancer cell type. [ Time Frame: Upon study completion (2-3 years) ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Cancer
  • Bone Metastases
  • 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 Name: PET Allegro scanner
  • 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 Name: Philips/ADAC Genesys gamma camera
  • 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.
    Intervention: 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.
    Intervention: Device: Tc-99m bone scan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
300
June 2015
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01254929
CAG00065R
No
David Djang, Seattle Nuclear Medicine
Seattle Nuclear Medicine
Not Provided
Principal Investigator: David Djang, MD Seattle Nuclear Medicine
Seattle Nuclear Medicine
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP