Multiparametric MRI for Prostate Cancer Localization and Characterization Using Hyperpolarized Pyruvate (13C) Injection
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|ClinicalTrials.gov Identifier: NCT02647983|
Recruitment Status : Recruiting
First Posted : January 6, 2016
Last Update Posted : April 10, 2019
Prostate cancer is the most common malignancy among men in the United States and Canada. Suspicion of prostate cancer with modern screening tests, such as digital rectal exam (DRE) and prostate serum antigen (PSA) require ultrasound-guided biopsy for pathological diagnosis. However, this technique misses cancer in nearly one quarter of patients and finds clinically insignificant disease in another third of patients, resulting in over-treatment and unnecessary morbidity.
MRI is the best imaging method for prostate cancer detection, but current techniques cannot reliably predict tumour grade and are often unreliable for localizing cancer, particularly within the transition zone, where specificity is low. The primary objective of this pilot study is to evaluate the added benefit of localizing prostate cancer and predicting tumour grade with Hyperpolarized 13C MRI, in addition to traditional T2-weighted and diffusion-weighted MR imaging.
The investigators propose a pilot study, in men diagnosed with prostate cancer awaiting prostatectomy, with the specific goals of comparing pre-operative imaging findings to ground truth histology, using whole-mount prostate specimens. The results of this study will provide insight into the prostate cancer disease signatures with MRI and determine if there is added benefit for incorporation of this new technique into future clinical MRI protocols. If future imaging tests could determine the size, grade and extent of disease, this would open the door for less invasive, localized treatment options with reduced morbidity.
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms||Drug: Hyperpolarized Pyruvate (13C) Injection||Phase 1|
The metabolism of 13C (non-radioactive) enriched pyruvate can be imaged by magnetic resonance (MR) spectroscopy when the nuclear spin of 13C is hyperpolarization enhanced. This technique allows in-vivo separation of [1-13C]pyruvate, [1-13C]lactate, [1-13C]alanine and [13C]bicarbonate signals following intravenous administration of Hyperpolarized Pyruvate (13C) Injection. The total 13C-signal detected in a given tissue depends on the dose administered and distribution to the tissue. The formation rate and relative levels of the metabolites depend on the metabolic needs of the specific tissue. Pre-clinical data indicate that some tumours show substantially higher levels and different ratios of specific metabolites when compared to corresponding normal tissue.
Soon after being taken up by cells within the prostate, [1-13C]pyruvate will be metabolized into various metabolites, including [1-13C]alanine and [13C]bicarbonate (via aerobic metabolism) and [1-13C]lactate (via anaerobic metabolism). It is expected that [1-13C]lactate will be formed in much higher amounts in malignant tissue, where the level of glycolysis is higher than in normal, BPH or inflamed tissues. Therefore, spectroscopic MR imaging of the prostate after administration of Hyperpolarized Pyruvate (13C) Injection, is expected to provide a robust, minimally invasive method to assist in detecting and characterizing prostate cancer, thereby determining which patients should receive further treatment and which should continue to be monitored via routine PSA and DRE testing.
This is a pilot prospective, single-institution study in men with biopsy-proven carcinoma of the prostate. Patient screening and accrual will be completed by a treating Urologist, Radiologist, or study nurse/coordinator. Clinical procedures will be completed at Sunnybrook Health Sciences Centre (SHSC). Eligible subjects will be undergoing radical prostatectomy at SHSC for biopsy-proven T1C disease (cancer found by elevated PSA and needle biopsy only) and serum PSA < 10. For the purpose of analysis, subjects will be divided into three groups based on the grade of cancer found on needle biopsy. A typical subject will be 50-80 years old. The length of this study for participants is approximately 1 hour of scan time.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multiparametric MRI for Prostate Cancer Localization and Characterization Using Hyperpolarized Pyruvate (13C) Injection|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||January 2020|
Experimental: Hyperpolarized Pyruvate (13C) Injection
Hyperpolarized Pyruvate (13C) Injection to be used a MRI contrast agent.
Drug: Hyperpolarized Pyruvate (13C) Injection
Hyperpolarized Pyruvate (13C) Injection is a MRI contrast agent.
- Ability of the MRI machine to produce an image of the participant's prostate following an injection of Hyperpolarized Pyruvate (13C) as assessed by the physician [ Time Frame: 2 years ]Feasibility of acquiring time resolved, 3D 13C lactate images from subjects with prostate cancer.
- Ability of the MRI machine to aid in predicting Gleason grade following an injection of Hyperpolarized Pyruvate (13C) as assessed by the physician [ Time Frame: 2 years ]
- Correlation between images obtained following Hyperpolarized Pyruvate (13C) Injection and the Gleason grade.
- Added value for localizing clinically significant prostate carcinoma and predicting Gleason grade
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): NCT02647983
|Contact: Julie Green, MSc||4164806100 ext firstname.lastname@example.org|
|Sunnybrook Health Sciences Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Julie Green, MSc 4164896100 ext 83655 email@example.com|
|Principal Investigator: Charles Cunningham, PhD|
|Principal Investigator:||Charles Cunningham, PhD||Sunnybrook Research Institute|