May 27, 2021

ACR CRI Supports its Sponsor Partner in FDA Approval of PET Imaging Radiotracer

The American College of Radiology® (ACR®) Center for Research and Innovation (CRI) managed imaging trial services for Progenics/Lantheus that resulted in data used to support the May 27 approval by the U.S. Food and Drug Administration (FDA) of positron emission tomography (PET) imaging radiotracer PYLARIFY, the first commercially available F-18 prostate-specific membrane antigen (PSMA) PET imaging agent for detection of recurrent and/or metastatic prostate cancer. The FDA approval was covered on NBC’s Today Show.

“We are proud to have played a critical role in helping Progenics/Lantheus, our sponsor partner, assess the efficacy of a new diagnostic to improve patient outcomes,” said American College of Radiology Chief Science Officer Etta Pisano, MD, FACR.

Comprised of more than 150 professionals with a variety of clinical research expertise, the ACR CRI provided centralized image collection and quality control services along with project and site management for a trial involving 212 subjects at 15 sites throughout the United States and Canada.

The CRI provided clinical research services at the level of regulatory rigor suitable for FDA submission and review, specifically, leading clinical site staff and physician reader training, authoring technical imaging specifications, qualifying PET scanners for research, and providing image quality control. All of these services aided in the FDA approval process.

“We work tirelessly to ensure the integrity and quality of data generated by participating sites and patients. This ensures our industry collaborators and regulatory authorities have reliable, robust information to evaluate new products,” said Pisano.

For more information on the American College of Radiology® (ACR®) Center for Research and Innovation visit