FDA Approves Tumor-Based MRI Contrast Agent for Prostate Cancer Detection

The U.S. Food & Drug Administration (FDA) has approved a tumor-targeting contrast agent that could potentially enable providers to accurately detect aggressive prostate cancer on an MRI scan.

Zheng-Rong Lu, Ph.D., Case Western Reserve University professor of biomedical engineering, developed the agent – MT218 – over the past 15 years. The Phase 1 clinical trial is set to begin in May at Ohio Clinical Trials Inc.

“We are very excited about this Phase 1 clinical trial because it means that our research product is now under clinical development to help people,” Lu said. “Our agent has the promise to detect the aggressive solid tumors to provide imaging guidance for precision healthcare of cancer patients.”

Currently, the gold standard for detecting and diagnosing prostate cancer is a 12-needle puncture biopsy guided by rectal ultrasound. The procedure can be painful, the biopsy can have sampling errors, and many tumors may co-exist – a perfect storm that can potentially lead to a false-negative diagnosis rate of up to 30 percent. In addition, relying extensively on blood test and subsequent biopsies can lead to over-diagnosis and over-treatment.

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“That’s why this is so important,” he explained. “Research shows that only 20 percent of patients diagnosed will develop aggressive tumors – so we could spare the other 80 percent from aggressive over-treatment.”

MT218, which is licensed to Molecular Theranostics LLC, a Cleveland-based start-up company, can potentially side-step these problems, Lu said. By using a patented gadolinium-based MRI contrast agent that binds to a molecular marker – extradomain B fibronectin, a cancer-associated subtype of fibronectin – the agent could potentially open the door for a more precise MRI scan for prostate cancer.

If successful, he said, clinicians could someday use MT218 in MRI scans to non-invasively and accurately diagnose malignant prostate cancer on a regular MRI scan without causing a patient undue discomfort. It could lead to a reduction in unnecessary interventions, as well as more accurately identify patients who could benefit from more aggressive treatments.

Lu said he anticipates 30 healthy African American and white males between ages 18 and 55 to participate in the first clinical trial.