Pegsitacianine Imaging for Head and Neck Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot take medications with a high chance of liver damage during the study. It's best to discuss your specific medications with the study team.
What data supports the effectiveness of the treatment Pegsitacianine for head and neck cancer?
While there is no direct data on Pegsitacianine, similar imaging agents have shown promise in improving the detection and treatment of head and neck cancers. For example, nanoparticles used in imaging have helped identify cancerous tissues and improve surgical precision, which could suggest potential benefits for Pegsitacianine in similar applications.12345
How does Pegsitacianine Imaging differ from other treatments for head and neck cancer?
Pegsitacianine Imaging is unique because it uses a near-infrared (NIR) fluorescence technique to help visualize tumors during surgery, which can improve the precision of tumor removal. This approach is different from traditional treatments that do not provide real-time imaging guidance during surgical procedures.678910
What is the purpose of this trial?
This is a non-randomized, open-label, single-center, safety and imaging feasibility study of Pegsitacianine, an intraoperative fluorescence imaging agent.
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Single dose of 1 mg/kg Pegsitacianine administered 6-100 hours prior to surgery for imaging primary tumors
Follow-up
Participants are monitored for safety and effectiveness after treatment, including vital signs, physical examination, and laboratory tests
Long-term monitoring
Participants are monitored for diagnostic performance and safety over a 5-year period
Treatment Details
Interventions
- Pegsitacianine
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator