FDA approves clinical trials to test the safety of cancer-detection technology

The U.S. Food and Drug Administration has approved human clinical trials to test the safety of cancer-detection technology developed at Case Western Reserve University: a tumor-targeting contrast agent that accurately detects aggressive prostate cancer in a magnetic resonance imaging (MRI) scan.

The molecular-targeted imaging agent is licensed to Molecular Theranostics LLC, a Cleveland based startup company, and its partners U.S. Motek LLC and Jiangsu Motek Pharmaceuticals Ltd. of China.

The agent will undergo a clinical trial at Ohio Clinical Trials Inc. in Columbus through a contract with U.S. Motek. Patient recruitment is expected to start in early May and the trial later in the month.

The imaging agent, known as MT218, was invented in the lab of Case Western Reserve researcher Zheng-Rong Lu, who has been developing the tumor-specific MRI contrast agent for nearly 15 years.

Lu, a co-founder of Molecular Theranostics, and his partners believe the agent could someday allow clinicians to non-invasively and accurately diagnose the malignant prostate cancer in a common MRI scan.

A more precise MRI scan of prostate cancer–and possibly other cancers–could benefit patients who are sometimes needlessly treated with aggressive interventions, or conversely, better identifying those who need the treatments, said Lu, the M. Frank Rudy and Margaret Domiter Rudy Professor of Biomedical Engineering at the Case School of Engineering.

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

Zheng-Rong Lu, Case Western Reserve Researcher

The key to this more precise diagnosis of the tumor is using Lu's patented gadolinium-based MRI contrast agent that binds to a molecular marker, called extradomain B fibronectin, a cancer-associated subtype of fibronectin.

The gadolinium agent is a paramagnetic substance that can enhance MRI signals of aggressive tumors to improve the accuracy of cancer diagnosis.

The clinical trials at Motek will assess whether the agent can be safely administered to humans–the first step in the clinical development for detecting the tumors in patients as it has done successfully in animal models, Lu said. The trial participants are expected to be 30 healthy Black and white males between age 18 and 55, he said.

A second trial is being pursued to test the agent's effectiveness in detecting aggressive tumors and differentiating the types of tumors, Lu said.

Lu's patented technology was jointly developed by Molecular Theranostics and its affiliates (U.S. Motek LLC and Jiangsu Motek Pharmaceuticals Ltd). Jiangsu Motek Pharmaceuticals announced the FDA approval in March.

Current prostate testing

Prostate cancer is the most common non-skin cancer in the United States: one in eight men nationally will be diagnosed with prostate cancer in his lifetime, according to the Prostate Cancer Foundation.

MRI provides high-resolution, three-dimensional tissue images and is widely used to diagnose prostate cancer.

However, the current technologies–especially MRI contrast agents added to tissues to reveal tumors–are limited. An imprecise diagnosis can lead to either over- or under-treating a tumor, Lu said.

Jiangsu Motek Pharmaceuticals officials said "the gold standard" for clinical diagnosis of prostate cancer is a 12-needle puncture biopsy guided by rectal ultrasound. However, sampling errors in the biopsy–and the fact that various levels of tumors may coexist in the prostate–can lead to a false-negative diagnosis rate of up to 30%, according to the company.

On the other hand, extensive blood tests for prostate cancer and a subsequent biopsy can sometimes lead to overdiagnosis and overtreatment. That overtreatment can lead to serious infections and reproductive and urinary side-effects, Lu said.

"That's why this is so important," said Lu. "Research shows that only 20% of patients diagnosed will develop aggressive tumors–so we could spare the other 80% from aggressive over treatment."