Magnetic Resonance Imaging (MRI) With Hyperpolarized Pyruvate (13C) as Diagnostic Tool in Advanced Prostate Cancer
Magnetic Resonance (MR) Imaging With Hyperpolarized Pyruvate (13C) as a Diagnostic and Response Monitoring Imaging Tool in Advanced Prostate Cancer
Ivan de Kouchkovsky, MD
75 participants
Jul 16, 2020
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria12
- 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:
- i. No contra-indications to endorectal coil insertion (e.g., patients with a prior abdominoperineal resection of the rectum or latex allergy).
- ii. No prior local treatment to the selected lesion, or evidence of radiographic progression following prior local therapy to selected lesion.
- Able and willing to comply with study procedures and provide signed and dated informed consent.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- For patients undergoing optional tumor biopsy:
- No history of bleeding diathesis.
- Patients on anti-coagulation they must be able to safely stop treatment for purposes of tumor biopsy.
Exclusion Criteria4
- 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
Interventions
Given by intravenous injection. When receiving two HP 13C pyruvate injections, the injections will be separated by a period of 15-60 minutes
Magnetic resonance imaging (MRI) is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in your body
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04346225