18F-NaF PET Imaging for Bone Scintigraphy
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.
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).
Bone Metastases From Breast or Prostate Cancer
Procedure: NaF PET/CT Imaging
Procedure: 99mTc-medronate whole body bone scan with SPECT
Drug: 18F-NaF (185-370 MBq)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||18F- Sodium Fluoride PET Imaging as a Replacement for Bone Scintigraphy|
- Accuracy, sensitivity, and specificity of 18F-Sodium Fluoride (18F-NaF) Positron Emission Tomography compared to 99mTc-Methylene Diphosphonate (MDP) bone SPECT imaging for detection of bone metastasis. [ Time Frame: At the 24 month post PET/CT follow-up physical examination. ] [ Designated as safety issue: No ]To compare the accuracy, sensitivity, and specificity of 18F-NaF imaging and 99mTc-MDP bone SPECT imaging for bone metastasis detection in patients with breast and prostate cancer.
- The secondary outcome is to monitor the short-term side-effects following 18F-NaF PET/CT to assess for adverse drug reactions [ Time Frame: Short-term side effects will be monitored for 24 hours following the injection of 18F-NaF (investigational product), and 72 hours following administration of 99mTc-MDP (standard treatment) ] [ Designated as safety issue: Yes ]Given that 18F-NaF is the investigational agent in this study, the collection of adverse events will focus on identifying potential events related to the administration of this radiopharmaceutical. Adverse events will also be collected for bone scanning with 99mTc-medronate.
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||November 2017|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
Experimental: NaF PET/CT
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.
Procedure: NaF PET/CT Imaging
diagnostic imaging test that is considered investigationalProcedure: 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-NaF (185-370 MBq)
|Contact: Francois Benard, MD||604-877-6000 ext 5979|
|Canada, British Columbia|
|BC Cancer Agency||Not yet recruiting|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Principal Investigator:||Francois Benard, MD||British Columbia Cancer Agency|