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


N/A
18 Years
N/A
Open (Enrolling)
Both
Cancer, Bone Metastases

Thank you

Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Accurate identification of bone metastases

Outcome Description:

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.

Outcome Time Frame:

Upon study completion (2-3 years)

Safety Issue:

No

Principal Investigator

David Djang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seattle Nuclear Medicine

Authority:

United States: Institutional Review Board

Study ID:

CAG00065R

NCT ID:

NCT01254929

Start Date:

December 2010

Completion Date:

December 2013

Related Keywords:

  • Cancer
  • Bone Metastases
  • Cancer
  • Bone metastases
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Bone Neoplasms
  • Bone Marrow Diseases

Name

Location

Seattle Nuclear MedicineSeattle, Washington  98104