NCT06831149 Use of SPY Imaging System to Minimize Fistulas After Hypopharyngeal Reconstruction
| NCT ID | NCT06831149 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Matthew Spector |
| Condition | Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 225 participants |
| Start Date | 2025-02-28 |
| Primary Completion | 2028-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 225 participants in total. It began in 2025-02-28 with a primary completion date of 2028-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Investigators performing this research want to look at the use of a special imaging process during a specific throat surgery. Using this imaging may help to lower a common complication that called a pharyngocutaneous fistula (PCF). A PCF is a leak in the tube in the throat that helps with breathing and digesting food. The imaging is called the SPY Fluorescence System. This system can identify tissue that is not receiving enough blood. The SPY Fluorescence System uses a special dye, called Indocyanine green (ICG) to better see the tissues that are not receiving enough blood. When tissue does not receive enough blood, it can lead to infection. Infection of tissue in this area of the throat can lead to PCF. The imaging takes about 1 minute and is performed in the operating room during surgery. For this study, the investigators (who are also surgeons) will decide to remove tissue that is identified by the SPY Fluorescence System to have decreased blood flow. They will then continue with the rest of the surgery as usual. The investigators will monitor participants as they recover from surgery to identify any complications that may occur. For this research they are interested in complications during the first month after surgery since this is when PCF usually happens. Investigators will use information that has been documented in the medical records of participants as well as during in-person physical examinations during inpatient recovery and outpatient clinical visits.
Eligibility Criteria
Inclusion Criteria: 1. Prior diagnosis of biopsy-proven squamous cell carcinoma of the larynx or hypopharynx (stage II-IV) 2. Prior treatment with radiation +/- chemotherapy 3. Presence of local recurrence of disease, radiation necrosis or an incompetent larynx 4. 18 years or older. 5. Ability to understand and sign informed consent Exclusion Criteria: 1. Iodine and Shellfish allergy 2. Contraindication to surgery under general anesthesia 3. Anticipated extended laryngectomy (laryngopharyngectomy or laryngopharyngoesophagectomy) with the need for free tissue transfer to reconstruct the pharyngeal mucosa. This may only be determined at the time of surgery 4. Pregnancy or lactation. 5. Patients residing in prison.
Contact & Investigator
Matthew E Spector, MD
PRINCIPAL INVESTIGATOR
University of Pittsburgh/UPMC
Frequently Asked Questions
Who can join the NCT06831149 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06831149 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06831149 currently recruiting?
Yes, NCT06831149 is actively recruiting participants. Contact the research team at spectorme@upmc.edu for enrollment information.
Where is the NCT06831149 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT06831149 clinical trial?
NCT06831149 is sponsored by Matthew Spector. The principal investigator is Matthew E Spector, MD at University of Pittsburgh/UPMC. The trial plans to enroll 225 participants.