A Phase 2a, Single-dose, Open-label Study to Evaluate Diagnostic Performance and Safety of Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer, in Patients With Unknown Primary Head and Neck Cancer (ILLUMINATE STUDY)

PHASE2RecruitingINTERVENTIONAL

Enrollment

120

Participants

Timeline

Start Date

April 17, 2024

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions

Head and Neck CancerUnknown Primary CancerHead and Neck Squamous Cell Carcinoma

Interventions

DRUG

Pegsitacianine

Infusion of the Pegsitacianine-Intraoperative fluorescence imaging

Trial Locations (1)

RECRUITING

University of Texas Southwestern Medical Center, Dallas

All Listed Sponsors

collaborator

National Cancer Institute (NCI)

NIH

lead

University of Texas Southwestern Medical Center

OTHER