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)

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT05576974
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Pegsitacianine — DRUG
    Infusion of the Pegsitacianine-Intraoperative fluorescence imaging

Study Details

This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent.

Key Dates

Start date
Apr 17, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Part 1 - Cohort A
    In Part 1 the single dose of 1 mg/kg of pegsitacianine given 6-300 hours prior to surgery will be used to image primary tumors in patients with HNSCC to evaluated to verify the diagnostic performance of pegsitacianine fluorescence imaging for detecting primary tumors and metastatic lymph nodes.
  • Active Comparator: Part 2 - Cohort B
    In Part 2, pegsitacianine the single dose of 1 mg/kg of given 6-300 hours prior to surgery will be used to in patients with unknown primary cancer of the head and neck. These patients typically undergo exam under anesthesia with a laryngoscopy as well as panendoscopy for identifying the source of the metastatic cancer found in the cervical nodes. The diagnostic performance of pegsitacianine fluorescence imaging for detecting primary tumors and metastatic lymph nodes in these patients will be evaluated. All the available data to date will be used to decide the additional tumor type(s), number of patients per tumor type, and number of Group(s) to be enrolled.

Primary Outcome Measure

Diagnostics performance and safety of 1 mg/kg Pegsitacianine in patients with HNSCC [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
[email protected]
2146488096
Baran Sumer, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Dallas, TX

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
University of Texas Southwestern Medical Center· Dallas, TX

Related Studies