18F-NaF PET Imaging for Bone Scintigraphy
- Conditions
- Bone Metastases From Breast or Prostate Cancer
- Interventions
- Procedure: NaF PET/CT ImagingProcedure: 99mTc-medronate whole body bone scan with SPECTDrug: 18F-Sodium Fluoride (NaF)
- Registration Number
- NCT01930812
- Lead Sponsor
- British Columbia Cancer Agency
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 286
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 18F-NaF PET Imaging for Bone Scintigraphy NaF PET/CT Imaging All participants will receive PET/CT Imaging using the investigational drug 18F-NaF and a 99mTc-medronate whole body bone scan with SPECT to compare the diagnostic ability of the two methods for the presence of bone metastases. 18F-NaF PET Imaging for Bone Scintigraphy 99mTc-medronate whole body bone scan with SPECT All participants will receive PET/CT Imaging using the investigational drug 18F-NaF and a 99mTc-medronate whole body bone scan with SPECT to compare the diagnostic ability of the two methods for the presence of bone metastases. 18F-NaF PET Imaging for Bone Scintigraphy 18F-Sodium Fluoride (NaF) All participants will receive PET/CT Imaging using the investigational drug 18F-NaF and a 99mTc-medronate whole body bone scan with SPECT to compare the diagnostic ability of the two methods for the presence of bone metastases.
- Primary Outcome Measures
Name Time Method 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. At the 24 month post PET/CT follow-up physical examination. 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.
- Secondary Outcome Measures
Name Time Method The secondary outcome is to monitor the short-term side-effects following 18F-NaF PET/CT to assess for adverse drug reactions 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) 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.
Trial Locations
- Locations (10)
BC Cancer Agency
🇨🇦Vancouver, British Columbia, Canada
Hamilton Health Sciences Corp.
🇨🇦Hamilton, Ontario, Canada
Centre hospitalier universitaire de Sherbrooke
🇨🇦Fleurimont, Quebec, Canada
QEII Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada
Edmonton Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
University Health Network
🇨🇦Toronto, Ontario, Canada
Centre hospitalier universitaire de Montréal
🇨🇦Montreal, Quebec, Canada
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
St. Joseph's Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada