- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02844647
Hyperpolarized Carbon-13 Imaging of Metastatic Prostate Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
"Hyperpolarization" of low natural abundance species such as 13C, offers the potential of extracting metabolic information by real-time imaging of biochemical reactions within the body. In this project, the investigators focus on prostate cancer, specifically late-stage disease, as management of these patients would benefit from a new imaging method that enables improved therapy selection, planning and monitoring.
For imaging the lactate distribution in bone-metastatic prostate cancer, 3D coverage of a large field-of-view is required in order to cover the vertebral column (the most common site of metastases). To enable this, the investigators have developed methods using a large-volume transmitter and multi-channel receiver system for 3-dimensional 13C metabolic imaging in these patients. The image resolution and encoding matrix were tailored to the required 3D coverage of the vertebral column.
At the end of this study, the investigators will have the methodology, hardware and clinical-research workflow needed to evaluate 13C-lactate imaging as a new tool to help patients with metastatic prostate cancer. The investigators would be the first in the world to apply 13C metabolic MRI to bone metastases. Although the investigators propose to study patients who are starting a 6-month course of treatment with radium 223, in this project, this proof-of-concept study may also lead to a larger clinical trial at different points in the treatment pathway, such as prior to deciding between treatment with cytotoxic agents versus drugs that target the androgen axis such as abiraterone.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Nadia Bragagnolo, MSc
- Phone Number: 83655 416.480.5021
- Email: nadia.bragagnolo@sunnybrook.ca
Study Locations
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men with bone-metastatic CRPC before starting the first dose of radium 223 therapy
- Laboratory requirements:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x109/L
- Hemoglobin ≥ 10.0 g/dL (100 g/L; 6.2 mmol/L)
- Total bilirubin level ≤ 1.5 institutional upper limit of normal (ULN)
- ASAT and ALAT ≤ 2.5 ULN
- • Creatinine ≤ 1.5 ULN
- Albumin >25 g/L
- Eastern Cooperative Oncology Group Status of 0 or 1
Exclusion Criteria:
- Unable to give valid informed consent
- Contraindication for MRI as per Sunnybrook MRI questionnaire (Appendix 1).
- Claustrophobia
- Body mass index of less than 18.5 or greater than 32
- Congestive heart failure, a past or present medical history of clinically significant electrocardiogram (EKG) abnormalities, which may include QT prolongation, a family history of prolonged QT interval syndrome, or a myocardial infarction (MI) within the past 12 months with ensuing unstable EKG, or ongoing acute or chronic pulmonary bronchospastic disease, including a history of chronic obstructive pulmonary disease or asthma, with an exacerbation within the past year
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MRI w/ Hyperpolarized Pyruvate (13C)
"Hyperpolarization" of low natural abundance species such as 13C, when injected offers the potential of extracting metabolic information by real-time MR imaging of biochemical reactions within the body.
The biochemical reactions, including lactate production, will be measured using MRI.
|
MRI contrast agent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Images of lactate, bicarbonate and pyruvate in patients with bone-metastatic CRPC measured by MRI
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 432-2015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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