Squamous Cell Carcinoma study: SPY-PHI vs ICG
Official title Use of SPY Imaging System to Minimize Fistulas After Hypopharyngeal Reconstruction
ClinicalTrials.gov ID: NCT06831149
What this study is testing
What is Indocyanine Green (ICG)?
An investigational imaging dye being studied to help reduce pharyngocutaneous fistula after throat surgery for squamous cell carcinoma. ICG is designed to fluoresce under near‑infrared light, allowing surgeons to see areas with reduced blood flow during the operation.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if using the SPY Fluorescence System during surgery can lower the rate of pharyngocutaneous fistulas, a common leak after throat reconstruction.
- Who it's for
- It is for adults who have squamous cell carcinoma of the hypopharynx and are undergoing reconstructive throat surgery.
- What's involved
- During surgery, the SPY system will be used for about one minute to spot tissue with poor blood flow. Surgeons may remove that tissue and then finish the operation as usual. After surgery, patients will be checked in the hospital and at follow‑up visits to look for complications.
- Time commitment
- Participants will stay in the hospital for recovery and have outpatient visits for up to one month after surgery to monitor for leaks and other issues.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Prior diagnosis of biopsy-proven squamous cell carcinoma of the larynx or hypopharynx (stage II-IV)
- Prior treatment with radiation +/- chemotherapy
- Presence of local recurrence of disease, radiation necrosis or an incompetent larynx
- 18 years or older. 5. Ability to understand and sign informed consent
You likely can't join if
- Iodine and Shellfish allergy
- Contraindication to surgery under general anesthesia
- Anticipated extended laryngectomy (laryngopharyngectomy or laryngopharyngoesophagectomy) with the need for free tissue transfer to reconstruct the...
- Pregnancy or lactation.
- Patients residing in prison.
The study team makes the final eligibility decision.
Where it is enrolling
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.