Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)Phase 2NCT07149207
Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors
A Phase 2 study testing Indocyanine Green (ICG) in people with Squamous Cell Carcinoma Head and Neck Cancer (HNSCC) and Margin Assessment, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study is for adult patients with head and neck cancer who are at risk of recurrence. The purpose of this study is to evaluate whether the use of Indocyanine Green (ICG) dye allows for better identification of tumor tissue during surgical procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma Head and Neck Cancer (HNSCC), Margin Assessment
- What is being tested?
- Indocyanine Green (ICG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2026to 7 Apr 2029
- 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
- Adult subjects at least 18 years of age.
- Subjects presenting with squamous cell carcinoma of mucosal origin and are at risk for recurrence.
- Good operative candidate as determined by the treating physician and/or multidisciplinary team.
- Subject capable of giving informed consent and participating in the process of consent.
- A WOCBP must be willing and able to use highly effective contraception from the time of informed consent throughout the study period. Acceptable forms of birth control include hormonal contraceptives (such as birth control pills, skin patch, vaginal ring, injection, and/or implant), intrauterine devices (IUDs), and barrier devices (such as condoms, diaphragm, cervical cap, and sponge).
Who cannot join
- Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study.
- A WOCBP who has had a positive urine or serum pregnancy test at the time of screening unless:
- they are menopausal defined by not having a menstrual cycle within the last 12 consecutive months or
- they have had a hysterectomy.
- Known allergy to iodides or shellfish.
- Inadequate organ function at time of screening as defined below:
Show all 10Show fewer
- Hepatic
- Total bilirubin >2 x Institutional Upper Limit of Normal (IULN). Participants with a history of Gilbert's disease must have total bilirubin <3mg/dL.
- AST (SGOT) and ALT (SPGT) >3 x IULN.
- Currently incarcerated individuals
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
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, 29425
HCC Clinical Trials Office, 843-792-9321, hcc-clinical-trials@musc.edu
About this study
This study is for adult patients with head and neck cancer who are at risk of recurrence. The purpose of this study is to evaluate whether the use of Indocyanine Green (ICG) dye allows for better identification of tumor tissue during surgical procedures. Participation will include standard of care visits along with administration of ICG dye and imaging during surgery. Participation in this study will last approximately 6 weeks.
- Being tested
- Indocyanine Green (ICG)
- Keywords
- Cancer, surgical margins, head and neck cancer, mucosal squamous cell cancer
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck, Neoplasms, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine Green (ICG)Drug
Dose: 5 mg/kg IV injection prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Single arm trial | Experimental | Not described Receives: Drug: Indocyanine Green (ICG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimates of sensitivity and specificity using ICG.
Sensitivity (specificity) will be estimated as the proportion of pathologically positive (negative) samples that do (do not) fluoresce using ICG.
Measured: From time of surgery until final pathology results are available (about 2 weeks)
Secondary outcomes (2)
Frequency and proportion of samples for which visualization is altered using dimension.
The frequency and proportion of samples for which visualization is altered (normal vs abnormal) will be summarized in each dimension (anterior, posterior, left and right lateral, superficial, deep).
Measured: From surgery until final pathology results are available (about 2 weeks)
Estimates of sensitivity and specificity using white light visualization.
Sensitivity and specificity point and interval estimates of white light visualization relative to pathology gold standard will be constructed as described for ICG.
Measured: From surgery until final pathology results are available (about 2 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start4 May 2026
- Primary completion7 Apr 2028 (estimated)
- Study completion7 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)Studies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Newman, MD, FACS, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149207
- Sponsor's protocol ID
- 103776
- Status last verified
- Jul 2026
- First submitted
- 31 Jul 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors
- ClinicalTrials.gov ID
- NCT07149207
- Acronym / sponsor ID
- 103776
- Keywords
- Cancer, surgical margins, head and neck cancer, mucosal squamous cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 4 May 2026 (actual)
- Primary completion
- 7 Apr 2028 (estimated)
- Study completion
- 7 Apr 2029 (estimated)
- First posted
- 29 Aug 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.
This study is for adult patients with head and neck cancer who are at risk of recurrence. The purpose of this study is to evaluate whether the use of Indocyanine Green (ICG) dye allows for better identification of tumor tissue during surgical procedures. Participation will include standard of care visits along with administration of ICG dye and imaging during surgery. Participation in this study will last approximately 6 weeks.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm trial | Experimental | Drug: Indocyanine Green (ICG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult subjects at least 18 years of age.
- Subjects presenting with squamous cell carcinoma of mucosal origin and are at risk for recurrence.
- Good operative candidate as determined by the treating physician and/or multidisciplinary team.
- Subject capable of giving informed consent and participating in the process of consent.
- A WOCBP must be willing and able to use highly effective contraception from the time of informed consent throughout the study period. Acceptable forms of birth control include hormonal contraceptives (such as birth control pills, skin patch, vaginal ring, injection, and/or implant), intrauterine devices (IUDs), and barrier devices (such as condoms, diaphragm, cervical cap, and sponge).
Key exclusion criteria (10 listed)
- Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study.
- A WOCBP who has had a positive urine or serum pregnancy test at the time of screening unless:
- Known allergy to iodides or shellfish.
- Inadequate organ function at time of screening as defined below:
- Currently incarcerated individuals
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 |
|---|---|---|
| Indocyanine Green (ICG)Dose: 5 mg/kg IV injection prior to surgery | Drug | Single arm trial |
Primary outcome
Estimates of sensitivity and specificity using ICG.
Time frame: From time of surgery until final pathology results are available (about 2 weeks)
Sensitivity (specificity) will be estimated as the proportion of pathologically positive (negative) samples that do (do not) fluoresce using ICG.
2 secondary outcomes
Frequency and proportion of samples for which visualization is altered using dimension.
Time frame: From surgery until final pathology results are available (about 2 weeks)
Estimates of sensitivity and specificity using white light visualization.
Time frame: From surgery until final pathology results are available (about 2 weeks).
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 7 Jul 2026.
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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.
Jason Newman, MD, FACS principal investigator
Medical University of South Carolina
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 Indocyanine Green (ICG) in people with Squamous Cell Carcinoma Head and Neck Cancer (HNSCC) and Margin Assessment, run by Medical University of South Carolina 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 5 inclusion and 10 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 7 Jul 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 HCC Clinical Trials Office (843-792-9321, hcc-clinical-trials@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimates of sensitivity and specificity using ICG. (time frame: From time of surgery until final pathology results are available (about 2 weeks)). 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 7 Jul 2026.