18F-FCH (Fluorocholine)-PET/MR in Staging of High-Risk Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01993160|
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : January 13, 2017
This is a single centre, single arm feasibility study of 18FCH PET-MR imaging for staging patients with high risk prostate cancer.
FCH-PET/MR will enable more accurate staging of patients with high risk prostate cancer as compared to conventional imaging.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Fluorocholine (18F-FCH) Injection Radiation: PET scan Radiation: Whole body MRI||Not Applicable|
Up to 60% of patients treated with radical prostatectomy or external beam radiotherapy for prostate cancer will have biochemical failure at 5 years. This may be due to several reasons, including presence of sub-clinical metastases at time of local therapy.
Currently, patients with high risk prostate cancer are staged by MRI of the prostate (to assess local extent of disease), CT of the abdomen(to detect spread to lymph nodes) and bone scan (to assess for spread to bones). However, these standard imaging exams do not always identify all sites of disease. Recent research has suggested that performing positron emission tomography (PET) scanning with a tracer called fluorocholine (FCH) improves identification of lymph node and bone metastases in prostate cancer, resulting in more accurate diagnosis.
The main goal of this study is to find out whether staging high risk prostate cancer patients with FCH PET-CT and MRI of the whole body will improve detection of primary tumors and metastases compared to current standard imaging exams. Improved staging of patients with prostate cancer may impact patient care as it will help to select more appropriate therapy.
In this study, participants will undergo either combined PET/MRI or PET-CT and MRI after standard evaluations. The accuracy of each staging approach (standard vs. PET and MRI) will be evaluated. In addition, we will incorporate novel methods for data interpretation by creating imaging maps combining data from PET and MRI (termed "Multiparametric maps"). The goal of this novel approach is to find out whether mapping 2 or more characteristics of a tumor at the same time will improve tumor detection and accuracy of diagnosis.
About 40 men from the Princess Margaret Hospital will take part in this study. The study should take about 2 years to complete enrollment and the results should be known within 36 months of completion of enrollment.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||18F-FCH-PET/MR in Staging of High-Risk Prostate Cancer: A Multiparametric Approach|
|Study Start Date :||December 2013|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: 18F-FCH PET MR
Integrated whole body PET-MR or PET-CT and separate whole body MRI with use of 18F-FCH as the molecular probe
Drug: Fluorocholine (18F-FCH) Injection
Before the PET-CT scan, the tracer (fluorocholine/FCH) will be injected into a vein in your arm just before the scan. This is the agent we are investigating in this study (not part of the standard procedure)
Radiation: PET scan
A whole body PET scan will be performed, integrated with either whole body low dose CT or whole body MRI
Radiation: Whole body MRI
A whole body MRI scan will be performed. This may be integrated with PET scan or performed separately.
- Number of prostate cancer foci detected with FCH PET/MR compared to MR alone. [ Time Frame: 2 years ]
- Detection rate of lymph node and distant metastases in patients with high risk prostate cancer as compared to conventional imaging strategies (CT abdomen and bone scintigraphy). [ Time Frame: 2 years ]
- Overall accuracy of multiparametric mapping of choline metabolism with various MR parameters in staging of patients with high risk prostate cancer as compared to conventional imaging strategies. [ Time Frame: 2 years ]
- Relationship of choline kinase activity in the primary tumor (as expressed by FCH uptake) to presence of hypoxia and expression of GLUT-1 transporter proteins in pathology specimens. [ Time Frame: 2 years ]
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): NCT01993160
|Princess Margaret Cancer Centre, University Health Network, 610 University Ave.|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Ur Metser, MD||University Health Network, Toronto|