Magnetic Resonance Imaging (MRI) With Hyperpolarized Pyruvate (13C) as Diagnostic Tool in Advanced Prostate Cancer

Launched by IVAN DE KOUCHKOVSKY, MD · Apr 10, 2020

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to use a special type of MRI, called hyperpolarized carbon-13 pyruvate MRI, to help diagnose and monitor advanced prostate cancer. The researchers believe that this imaging technique can detect aggressive forms of prostate cancer and may show how well patients are responding to treatment. The aim of the study is to learn more about how effective this MRI method can be for patients with advanced stages of the disease.

To be eligible for this trial, participants must be men aged 65 to 74 who have been diagnosed with either locally advanced or metastatic prostate cancer. They should have at least one specific area of cancer that can be seen on standard imaging tests like CT or MRI. Participants will undergo MRI scans and may also have the option for a tumor biopsy. It’s important for potential participants to know that they must be able to safely undergo an MRI and provide consent to join the study. The research team is currently recruiting participants, and they will guide and support everyone involved throughout the trial.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• 2. 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:
• • 1. Soft tissue/visceral organ target lesions must measure at 1 cm in long axis diameter on CT or MRI.
• • 2. Target lesions in the bone must be visualized by CT or MRI (lesions present only on bone scan do not qualify).
• 3. 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.
• • 3. Able and willing to comply with study procedures and provide signed and dated informed consent.
• • 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• 5. For patients undergoing optional tumor biopsy:
• • 1. No history of bleeding diathesis.
• • 2. Patients on anti-coagulation they must be able to safely stop treatment for purposes of tumor biopsy.
• Exclusion Criteria:
• • 1. Patients who because of age, general medical or psychiatric condition, or physiologic status cannot give valid informed consent.
• • 2. 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.
• • 3. Metallic hip implant or any other metallic implant or device that distorts local magnetic field and compromises the quality of MRI.
• • 4. Any condition that, in the opinion of the Principal Investigator, would impair the patient's ability to comply with study procedures