Squamous Cell CarcinomaPhase 2NCT06831149
Use of SPY Imaging System to Minimize Fistulas After Hypopharyngeal Reconstruction
A Phase 2 study testing Removal of pharyngeal mucosa with decreased perfusion will be performed, SPY-PHI and ICG (Indocyanine Green) in people with Squamous Cell Carcinoma and Pharyngocutaneous Fistula, run by Matthew Spector at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma, Pharyngocutaneous Fistula
- What is being tested?
- Removal of pharyngeal mucosa with decreased perfusion will be performed, SPY-PHI and ICG (Indocyanine Green)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2025to 28 Feb 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 pharyngeal mucosa. This may only be determined at the time of surgery
- Pregnancy or lactation.
- Patients residing in prison.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UPMC
Pittsburgh, Pennsylvania, 15213
Matthew E Spector, MD, 412-647-2100, spectorme@upmc.edu
About this study
Official title: A Phase 2 Trial of Intraoperative Fluorescent Angiography to Decrease Pharyngocutaneous Fistula Rates in Patients Undergoing Hypopharyngeal Reconstruction
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.
Read more
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.
Read the detailed description
Our prior work has demonstrated the efficacy to predict pharyngocutaneous fistula using Indocyanine green (ICG) angiography. In an observational study of 41 patients who underwent salvage TL with onlay free flap reconstruction, 7 (17%) patients developed PCF. Intraoperative angiography has the ability to measure the blood flow rate (ingress) into the tissues. In patients with ingress <15 (n=25), 24% developed a PCF. In contrast, no PCF was seen in the group with ingress >15. Of note, in patients with ingress <15, there was no intervention performed as this was an observational study.
- Conditions
- Squamous Cell Carcinoma, Pharyngocutaneous Fistula
- Being tested
- Removal of pharyngeal mucosa with decreased perfusion will be performed, SPY-PHI, ICG (Indocyanine Green)
- Keywords
- squamous cell carcinoma hypopharynx, squamous cell carcinoma larynx, SPY Fluorescence Imaging System
- Medical subject headings
- Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Removal of pharyngeal mucosa with decreased perfusion will be performedProcedure or surgery
Surgical removal of underperfused tissue versus nonremoval of tissue
SPY-PHIDevice
SPY Portable Handheld Imaging (SPY-PHI)
ICG (Indocyanine Green)Drug
ICG will be used in conjunction with the SPY-PHI system for tissue imaging.
| Study group | Role | What they receive |
|---|---|---|
| Patients having salvage TL after failure with radiation or chemoradiation | Other | SPY intraoperative fluorescent angiography system to risk stratify patients intraoperatively into low and high risk groups for developing pharyngocutaneous fistula (PCF) postoperatively Receives: Procedure: Removal of pharyngeal mucosa with decreased perfusion will be performed; Device: SPY-PHI; Drug: ICG (Indocyanine Green) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PCF, within one month post total laryngectomy (TL)
Incidence of PCF, in participants identified as "high risk", utilizing the SPY Fluorescence Imaging System during total laryngectomy (TL) surgical procedure, within one month post TL. Incidence of PCF will be monitored during post operative, inpatient hospitalization as well as clinical outpatient follow up.
Measured: From enrollment through 1 month post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start28 Feb 2025
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, interventional
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matthew Spector
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Matthew Spector, University of Pittsburgh
- Investigators
- Matthew E Spector, MD, Principal investigator, University of Pittsburgh/UPMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831149
- Sponsor's protocol ID
- STUDY24100162
- Status last verified
- Jan 2026
- First submitted
- 13 Feb 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: At the time of creation of the project, the investigators do not envision the need to share IPD with other researchers or other entities. The funding for the project is internal so there is no need to report to an external sponsor.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial of Intraoperative Fluorescent Angiography to Decrease Pharyngocutaneous Fistula Rates in Patients Undergoing Hypopharyngeal Reconstruction
- ClinicalTrials.gov ID
- NCT06831149
- Acronym / sponsor ID
- STUDY24100162
- Conditions
- Squamous Cell Carcinoma, Pharyngocutaneous Fistula
- Keywords
- squamous cell carcinoma hypopharynx, squamous cell carcinoma larynx, SPY Fluorescence Imaging System
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Matthew SpectorUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Our prior work has demonstrated the efficacy to predict pharyngocutaneous fistula using Indocyanine green (ICG) angiography. In an observational study of 41 patients who underwent salvage TL with onlay free flap reconstruction, 7 (17%) patients developed PCF. Intraoperative angiography has the ability to measure the blood flow rate (ingress) into the tissues. In patients with ingress <15 (n=25), 24% developed a PCF. In contrast, no PCF was seen in the group with ingress >15. Of note, in patients with ingress <15, there was no intervention performed as this was an observational study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, interventional
| Arm | Type | Receives |
|---|---|---|
| Patients having salvage TL after failure with radiation or chemoradiation | Other | Procedure: Removal of pharyngeal mucosa with decreased perfusion will be performed, Device: SPY-PHI, Drug: ICG (Indocyanine Green)SPY intraoperative fluorescent angiography system to risk stratify patients intraoperatively into low and high risk groups for developing pharyngocutaneous fistula (PCF) postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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 pharyngeal mucosa. This may only be determined at the time of surgery
- Pregnancy or lactation.
- Patients residing in prison.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Removal of pharyngeal mucosa with decreased perfusion will be performedSurgical removal of underperfused tissue versus nonremoval of tissue | Procedure or surgery | Patients having salvage TL after failure with radiation or chemoradiation |
| SPY-PHISPY Portable Handheld Imaging (SPY-PHI) | Device | Patients having salvage TL after failure with radiation or chemoradiation |
| ICG (Indocyanine Green)ICG will be used in conjunction with the SPY-PHI system for tissue imaging. | Drug | Patients having salvage TL after failure with radiation or chemoradiation |
Primary outcome
Incidence of PCF, within one month post total laryngectomy (TL)
Time frame: From enrollment through 1 month post surgery
Incidence of PCF, in participants identified as "high risk", utilizing the SPY Fluorescence Imaging System during total laryngectomy (TL) surgical procedure, within one month post TL. Incidence of PCF will be monitored during post operative, inpatient hospitalization as well as clinical outpatient follow up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No. At the time of creation of the project, the investigators do not envision the need to share IPD with other researchers or other entities. The funding for the project is internal so there is no need to report to an external sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew E Spector, MD principal investigator
University of Pittsburgh/UPMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Removal of pharyngeal mucosa with decreased perfusion will be performed, SPY-PHI and ICG (Indocyanine Green) in people with Squamous Cell Carcinoma and Pharyngocutaneous Fistula, run by Matthew Spector at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew E Spector, MD (412-647-2100, spectorme@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of PCF, within one month post total laryngectomy (TL) (time frame: From enrollment through 1 month post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.