18F-NaF PET Imaging for Bone Scintigraphy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01930812|
Recruitment Status : Completed
First Posted : August 29, 2013
Last Update Posted : April 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bone Metastases From Breast or Prostate Cancer||Procedure: NaF PET/CT Imaging Procedure: 99mTc-medronate whole body bone scan with SPECT Drug: 18F-Sodium Fluoride (NaF)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||286 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||18F- Sodium Fluoride PET Imaging as a Replacement for Bone Scintigraphy|
|Actual Study Start Date :||July 2014|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 31, 2019|
Experimental: 18F-NaF PET Imaging for Bone Scintigraphy
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.
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
- 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. ]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) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930812
|Edmonton Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|BC Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Canada, Nova Scotia|
|QEII Health Sciences Centre|
|Halifax, Nova Scotia, Canada, B3H 2Y9|
|Hamilton Health Sciences Corp.|
|Hamilton, Ontario, Canada, L8N 3Z5|
|St. Joseph's Healthcare Hamilton|
|Hamilton, Ontario, Canada, L8N 4A6|
|London Health Sciences Centre|
|London, Ontario, Canada, N6A 5A5|
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1H 8L6|
|University Health Network|
|Toronto, Ontario, Canada, M5G 2M9|
|Centre hospitalier universitaire de Sherbrooke|
|Fleurimont, Quebec, Canada, J1H 5N4|
|Centre hospitalier universitaire de Montréal|
|Montreal, Quebec, Canada, H2L 4M1|
|Principal Investigator:||Francois Benard, MD||British Columbia Cancer Agency|