Phase 2a Study on Using Pegsitacianine for Detecting Cancer in Patients with Unknown Primary Head and Neck Cancer (ILLUMINATE STUDY)

Sponsor: University of Texas Southwestern Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05576974

Provider View

This study is testing a new imaging agent called Pegsitacianine to see if it can help detect head and neck cancers during surgery. The study aims to evaluate the safety and effectiveness of this agent in patients with known or unknown primary head and neck cancer.

Patient Parameters

Program Overview

The purpose of this study is to test if Pegsitacianine, a new imaging agent, can help doctors see head and neck cancers during surgery. The study will check if this agent is safe and effective in patients who are having surgery to diagnose, evaluate, or remove their cancer. The study is divided into two parts, focusing on different types of head and neck cancers.

Description

This study is exploring the use of Pegsitacianine, a special imaging agent, to help doctors see head and neck cancers during surgery. The study is open-label, meaning both the doctors and patients know what treatment is being given, and it takes place at a single medical center.

The main goal is to find out if Pegsitacianine can help image cancers in the head and neck area, including cases where the primary cancer site is unknown. Patients will receive a single dose of Pegsitacianine, and doctors will use it to try to see the cancer during surgery, between 6 to 100 hours after the dose.

The study has two parts:

  • Part 1: Involves patients with known head and neck squamous cell carcinoma (HNSCC) who are undergoing routine surgery. They will receive a single dose of Pegsitacianine to help image their tumors.
  • Part 2: Involves patients with unknown primary cancer of the head and neck (UPC) who have cancer spread to at least one neck lymph node but no known primary tumor. They will also receive a single dose of Pegsitacianine for imaging purposes.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older.
  • Have a confirmed diagnosis of head and neck cancer, either primary or recurrent, or a high suspicion of cancer.
    • For Part 1: Have stage 1 to 4 head and neck squamous cell carcinoma (HNSCC).
    • For Part 2: Have unknown primary cancer with cancer spread to at least one neck lymph node and no known primary tumor.
  • Have acceptable blood, kidney, and liver function as required for surgery.
  • Women of childbearing potential must have a negative pregnancy test.
  • Agree to use effective birth control during the study and for 6 months after.
  • Agree not to drink alcohol from 72 hours before receiving Pegsitacianine until the end of the study visit.
  • Must be able to attend follow-up appointments.

Exclusion Criteria

  • Tumors in locations where imaging during surgery is not possible.
  • Life expectancy of less than 12 weeks.
  • Poor overall health with a performance status below 70%.
  • Significant liver disease or active hepatitis.
  • Any medical condition that would prevent surgery.
  • Unable to give informed consent due to medical or psychiatric conditions.
  • Pregnant or breastfeeding women.
  • Taking medications that could harm the liver during the study.
  • Consumed alcohol within 72 hours before receiving Pegsitacianine.
  • Participated in another clinical trial within 30 days before receiving Pegsitacianine.
  • Unable to follow the study schedule or any condition that could affect the study results.
  • The study doctor believes the patient should not participate.

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