# 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)

> **NCT05576974** · PHASE2 · RECRUITING · sponsor: **University of Texas Southwestern Medical Center** · enrollment: 120 (estimated)

## Conditions studied

- Head and Neck Cancer
- Unknown Primary Cancer
- Head and Neck Squamous Cell Carcinoma

## Interventions

- **DRUG:** Pegsitacianine

## Key facts

- **NCT ID:** NCT05576974
- **Lead sponsor:** University of Texas Southwestern Medical Center
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2024-04-17
- **Primary completion:** 2027-12-31
- **Final completion:** 2027-12-31
- **Target enrollment:** 120 (ESTIMATED)
- **Last updated:** 2026-04-14

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05576974

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05576974, "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)". Retrieved via AI Analytics 2026-06-30 from https://api.ai-analytics.org/clinical/NCT05576974. Licensed CC0.

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