ILLUMINATE Study: Pegsitacianine for Head and Neck Cancer Imaging
This study is testing a new imaging agent called Pegsitacianine to see if it can help doctors find head and neck cancers, including those where the original tumor location is unknown (unknown primary cancer). You might be able to join if you are an adult (18-99 years old) with a confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) or unknown primary head and neck cancer. The study will look at how well Pegsitacianine helps doctors see these cancers during surgery and if it is safe to use. The goal is to see if this agent can improve how doctors detect these cancers. The current recruitment status is unclear, and the study plans to enroll 120 participants.
- Study design
- This is a Phase 2a, single-dose, open-label study, meaning you and your doctors will know you are receiving Pegsitacianine. It is not randomized and will be conducted at a single center, with 120 planned participants.
- What's involved
- You would receive a single infusion of Pegsitacianine and then undergo routine surgery for biopsy, evaluation, detection, or removal of your cancer between 6 and 300 hours after the dose.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess diagnostic performance and safety for up to 5 years after receiving Pegsitacianine.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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)
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Diagnostics performance and safety of 1 mg/kg Pegsitacianine in patients with HNSCC5 years
Pegsitacianine fluorescence from in vivo and excised tissues will be imaged using intraoperative and post-operative NIR cameras and will be correlated with the histopathological confirmation of tumor and normal tissues to determine Pegsitacianine's diagnostic performance. Patient safety will be assessed for 10 days (±48 hours) post dose. All patients will be monitored for vital signs and physical examination pretreatment and at various time points up to Day 6 (±24 hours). All patients will be monitored for comprehensive metabolic panel (CMP) and complete blood count (CBC) with differentials pretreatment and at various time points up to Day 10 (±48 hours). All patients will be monitored for TEAEs, and concomitant medication use from the start of dosing up to Day 10 (±48 hours). TEAEs will be followed closely during the study to identify any potential DLTs
- Diagnostics performance and safety of 1 mg/kg Pegsitacianine in patients with UPC5 years
Pegsitacianine fluorescence from in vivo and excised tissues will be imaged using intraoperative and post-operative NIR cameras and will be correlated with the histopathological confirmation of tumor and normal tissues to determine Pegsitacianine's diagnostic performance. Patient safety will be assessed for 10 days (±48 hours). All patients will be monitored for vital signs and physical examination pretreatment and at various time points up to Day 6 (±48 hours). All patients will be monitored for comprehensive metabolic panel (CMP) and complete blood count (CBC) with differentials pretreatment and at various time points up to Day 10 (±48 hours). All patients will be monitored for TEAEs, and concomitant medication use from the start of dosing up to Day 10 (±48 hours). TEAEs will be followed closely during the study to identify any potential DLTs