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Pegsitacianine Imaging for Head and Neck Cancer

Phase 2
Recruiting
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Summary

This trial will study a new imaging agent to help assess a surgical site during an operation.

Who is the study for?
Adults over 18 with certain types of head and neck cancers, including those without a known primary tumor location but with metastatic disease. Participants must have proper organ function, agree to use contraception, and avoid alcohol before the trial. Those very ill or unable to consent are excluded.
What is being tested?
The study is testing Pegsitacianine as an imaging agent during surgery for cancer detection in patients with head and neck cancers. It's an open-label trial where all participants receive the agent to assess its safety and effectiveness in identifying cancerous tissue.
What are the potential side effects?
Specific side effects of Pegsitacianine aren't detailed here, but potential risks may include allergic reactions or issues related to contrast agents such as nausea or skin irritation. Safety evaluations will be part of the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Diagnostics performance and safety of 1 mg/kg Pegsitacianine in patients with HNSCC
Diagnostics performance and safety of 1 mg/kg Pegsitacianine in patients with UPC
Secondary study objectives
Malignant Neoplasms

Trial Design

2Treatment groups
Active Control
Group I: Part 1 - Cohort AActive Control1 Intervention
In Part 1 the single dose of 1 mg/kg of pegsitacianine given 6-100 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.
Group II: Part 2 - Cohort BActive Control1 Intervention
In Part 2, pegsitacianine the single dose of 1 mg/kg of given 6-100 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.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,855 Previous Clinical Trials
41,005,988 Total Patients Enrolled
University of Texas Southwestern Medical CenterLead Sponsor
1,075 Previous Clinical Trials
1,056,376 Total Patients Enrolled

Media Library

Part 1 - Cohort A Clinical Trial Eligibility Overview. Trial Name: NCT05576974 — Phase 2
Head and Neck Cancers Research Study Groups: Part 1 - Cohort A, Part 2 - Cohort B
Head and Neck Cancers Clinical Trial 2023: Part 1 - Cohort A Highlights & Side Effects. Trial Name: NCT05576974 — Phase 2
Part 1 - Cohort A 2023 Treatment Timeline for Medical Study. Trial Name: NCT05576974 — Phase 2
~27 spots leftby Dec 2027
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