Magnetic Resonance Imaging (MRI) With Hyperpolarized Pyruvate (13C) as Diagnostic Tool in Advance… (NCT04346225) | Clinical Trial Compass
SuspendedPhase 2
Magnetic Resonance Imaging (MRI) With Hyperpolarized Pyruvate (13C) as Diagnostic Tool in Advanced Prostate Cancer
Stopped: Due to funding
United States75 participantsStarted 2020-07-16
Plain-language summary
This is a prospective imaging study evaluating the utility of baseline metabolic MR imaging as a diagnostic and response monitoring tool in patients with advanced prostate cancer. Preliminary pre-clinical and clinical data demonstrates the ability of HP C-13 pyruvate/metabolic MR imaging to detect high-grade prostate cancer, including cancer with neuroendocrine differentiation, as well as provide early evidence of metabolic response and resistance following application of systemic therapies for the treatment of advanced prostate cancer patients. In the proposed study, the investigators aim is to extend the initial clinical results and further develop HP C-13 MRI as an imaging modality in advanced prostate cancer.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically-confirmed locally advanced or metastatic prostate cancer. Patients with unequivocal clinical evidence supporting diagnosis of prostate cancer who have not had prior biopsy may be considered eligible per judgment of Principal Investigator.
. Presence of at least one target lesion detected by standard staging scans that, in the judgment of Study Investigators, would be amenable to hyperpolarized C-13 pyruvate/metabolic MR imaging:
. Soft tissue/visceral organ target lesions must measure at 1 cm in long axis diameter on CT or MRI.
. Target lesions in the bone must be visualized by CT or MRI (lesions present only on bone scan do not qualify).
. For patients with target lesion in prostate/prostatic bed:
. Able and willing to comply with study procedures and provide signed and dated informed consent.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pyruvate to lactate (kPL) metabolic flux within target lesion (Cohort A)
Timeframe: 1 day
2
Pyruvate to glutamate (kPG) metabolic flux within target lesion (Cohort A).
Timeframe: 1 day
3
Mean percent change from baseline in intra-tumoral kPL within target lesion after treatment. (Cohort B)
Timeframe: Up to 8 weeks
4
Mean percent change from baseline in intra-tumoral kPG within target lesion after treatment.
. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
. For patients undergoing optional tumor biopsy:
Exclusion criteria
. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
. Patients unwilling or unable to undergo MR imaging, including patients with contra- indications to MRI, such as cardiac pacemakers or non-compatible intracranial vascular clips.
. Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MRI.
. Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures