NCT01930812

18F-NaF PET Imaging for Bone Scintigraphy

18F- Sodium Fluoride PET Imaging as a Replacement for Bone Scintigraphy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 286 (actual)
• Sponsor: British Columbia Cancer Agency · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare, in patients with prostate or breast cancer, the accuracy of 18F-NaF PET imaging to 99mTc whole body bone scans with single-photon emission computed tomography (SPECT).

Detailed description

Technetium-99m (99mTc) is the most widely used radionuclide in diagnostic nuclear medicine studies. It is used in 20 million diagnostic procedures worldwide annually. It became popular as a radioisotope because of its easy availability from a 99Molybdenum (99Mo)/99mTc generator, historic low costs, and previous high availability. The National Research Universal (NRU) reactor at Chalk River Laboratories (Ontario, Canada) was shut down unexpectedly in May 2009 following a leak of heavy water. The NRU reactor supplied approximately a third of the world's demand of 99Mo for 99Mo/99mTc generators used diagnostic nuclear medicine tests. Given the fragility of 99Mo supply, alternative radiopharmaceuticals, such as 18F-Sodium Fluoride (18F-NaF), are attractive options to replace 99mTc bone scans. Several studies suggest that 18F-NaF may be more accurate and more sensitive in the detection of bone metastases than 99mTc bone scans.

Conditions

• Bone Metastases From Breast or Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	NaF PET/CT Imaging	Diagnostic imaging test that is considered investigational
PROCEDURE	99mTc-medronate whole body bone scan with SPECT	99mTc-medronate whole body bone scan with SPECT imaging. Note, that this is a standard procedure in this patient population and thus is not considered investigational.
DRUG	18F-Sodium Fluoride (NaF)	A single radioactive dose of 18F-NaF (185-370 MBq) is intravenously administered to subject 60 minutes prior to PET/CT imaging to evaluate whether or not subject has bone metastasis from advanced prostate or breast cancer. Entire procedure from injection to scan completion will take about 2.25 hours

Timeline

• Start date: 2014-07-01
• Primary completion: 2017-03-01
• Completion: 2019-03-31
• First posted: 2013-08-29
• Last updated: 2019-04-25

Locations

10 sites across 1 country: Canada