Patient Recruitment Underway in US and Netherlands for Innovative Drug Trial

OCT CRO is excited to announce that patient enrollment has officially begun in the USA and the Netherlands for an innovative Phase 2/3 study, an investigational fluorescent contrast agent. 

This significant milestone follows a successful interim analysis, which allowed the study to advance into the blinded portion of the research. The study is evaluating an intravenously administered fluorescent contrast agent designed for visualization during abdominopelvic surgeries that require ureter identification. 

OCT is providing comprehensive management for this study. The Phase 2/3 study is specifically designed for subjects scheduled to undergo abdominopelvic surgery during which one or more ureters should be visualized during the procedure, utilizing the fluorescent contrast administered intravenously by bolus.

Phase 2 focused on dose evaluation, originally planned across three dose cohorts of twelve subjects each, totaling thirty-six patients. Following the Dose Selection Meeting, the near-optimal dose was confirmed as 2.5 mg. Phase 2 has now been successfully completed, with patients having been enrolled exclusively into two cohorts, and no additional cohorts were included.

Patient enrollment is now actively underway for Phase 3A — a randomized controlled trial targeting 100 patients. The study employs a 1:1 randomization scheme: 50 patients in the treatment arm receiving the investigational drug plus NIR camera imaging, and 50 patients in the control arm receiving placebo plus NIR camera imaging. Patients in the treatment arm may receive up to three injections of the 2.5 mg dose established in Phase 2, administered at the surgeon's discretion.

The current enrollment status shows different progression across regions: US sites continue Phase 3A enrollment (81 of 100 patients already recruited), while sites in the Netherlands have advanced to Phase 3B — a randomized crossover trial targeting 200 patients. This parallel execution across three US and five Dutch sites demonstrates efficient study management and operational excellence.

A significant hurdle encountered during recruitment involved restrictive inclusion criteria, which excluded patients with a prior history of abdominopelvic surgery, major abdominopelvic trauma, abdominal or pelvic radiation treatment, intraperitoneal therapy, inflammatory bowel disease, diverticular disease, endometriosis, pelvic inflammatory disease, or peritonitis. Through detailed discussions with our clinical centers, we successfully addressed these issues. The sponsor subsequently issued a protocol amendment, a measure which has significantly accelerated patient enrollment. This proactive approach and effective site communication proved instrumental in overcoming this critical recruitment challenge.

OCT is providing the following services: site management, project management, and data management, covering both MedDRA and WHODrug coding.

OCT CRO possesses proven expertise in the organization and management of clinical research. We offer a full spectrum of services, ranging from the development of clinical study design and services for medical writing and scientific clinical research consulting, all the way through to comprehensive project support aimed at drug registration. To calculate costs and discuss your project, please send an inquiry to info@oct-cro.com.