Fluorescent Imaging of Nerves With Illuminare-1 During Surgery

Summary

This study will test the safety of using Illuminare-1 during standard surgery for prostate cancer. The study researchers will test increasing doses of Illuminare-1 to find the dose that makes the nerve structures fluoresce (light up) but causes few or mild side effects. When the researchers find this dose, it will be tested in new groups of study participants to see whether surgery performed using Illuminare-1 guidance is better than surgery performed without intraoperative guidance. The researchers will also do tests to study the way the body absorbs, distributes, and gets rid of Illuminare-1. This study is the first to test Illuminare-1 in people. Illuminare-1 has received Fast Track designation from the US FDA.

Timeline

Start

2021-10-04

Primary completion

2025-09-09

Completion

2025-09-09

Publications

• Gold SA, Pere MM, Assel M, Doudt AD, Durdin TD, Silagy AW, Dean LW, Recabal P, Levine E, Burke A, Ragupathi G, Marzabadi MR, Yao ZK, Yang G, Yang G, Ouerfelli O, McCarter M, Chen X, Tzatha E, Coleman JA, Goh AC, Smith RC, Ehdaie B, Vickers AJ, Scardino PT, Eastham JA, Laudone VP, Donahue TF. Rizedisben in Minimally Invasive Surgery: A Nonrandomized Clinical Trial. JAMA Surg. 2025 Aug 1;160(8):875-883. doi: 10.1001/jamasurg.2025.1987.

Drugs

Indications