Prospective Study Using Hybrid PET/MRI to Evaluate Men With Suspected Recurrence Following Treatment for Prostate Cancer (IGPC-3)
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|ClinicalTrials.gov Identifier: NCT01804231|
Recruitment Status : Completed
First Posted : March 5, 2013
Last Update Posted : July 30, 2018
Evaluate the impact of hybrid 18F-Fluoro-choline (18F-FCH) PET/MRI imaging on the clinical management of men with suspected recurrent prostate cancer post prostatectomy or radiotherapy.
We hypothesize that hybrid imaging incorporating 18F-FCH PET/MRI imaging will be feasible and will lead to changes in management decisions among men being re-staged for suspected prostate cancer recurrence post-surgery or radiation who are potentially eligible for local salvage therapy.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: 18F-FCH PET/MRI imaging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Study of Hybrid PET/MRI in the Evaluation of Men With Suspected Prostate Cancer Recurrence Following Definitive Local Therapy|
|Actual Study Start Date :||July 9, 2013|
|Actual Primary Completion Date :||December 15, 2015|
|Actual Study Completion Date :||October 12, 2016|
18F-FCH PET/MRI imaging
Patients eligible for the study will have an 18F-FCH PET/MRI in addition to standard of care clinical assessment and imaging (CT and bone scan)
Other: 18F-FCH PET/MRI imaging
Patients will first undergo screening to ensure eligibility. If eligible, they will undergo one scan in a Hybrid PET/MRI scanner using 18F-FCH as the radiolabeled tracer.
- Frequency in change of clinical management based on results of 18F-FCH PET/MRI [ Time Frame: Within 2 weeks of study scan ]A questionnaire to assess the planned management will be completed by the investigator before and after provision of the results of the 18F-FCH PET/MRI to determine if the information provided by 18F-FCH PET/MRI influences the preferred plan of management
- Number of lesions identified with 18F-FCH based on consensus reporting [ Time Frame: Within 2 weeks of study scan ]
- Concordance between MRI and 18F-FCH PET for lesion identification [ Time Frame: Within 2 weeks of study scan ]Lesions identified on the 18F-FCH MRI/PET will be examined to determine what proportion of lesions are present on both MRI and PET imaging versus what proportion of lesions are present on only one of MRI or PET
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): NCT01804231
|London Health Sciences Centre|
|London, Ontario, Canada, N6A 5W9|
|Principal Investigator:||Dr. Glenn S Bauman, MD||London Health Sciences Centre|