NCT07149207 Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors
| NCT ID | NCT07149207 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Medical University of South Carolina |
| Condition | Squamous Cell Carcinoma Head and Neck Cancer (HNSCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-05-04 |
| Primary Completion | 2028-04-07 |
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 30 participants in total. It began in 2026-05-04 with a primary completion date of 2028-04-07.
⚠ 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
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.
Eligibility Criteria
Inclusion Criteria: 1. Adult subjects at least 18 years of age. 2. Subjects presenting with squamous cell carcinoma of mucosal origin and are at risk for recurrence. 3. Good operative candidate as determined by the treating physician and/or multidisciplinary team. 4. Subject capable of giving informed consent and participating in the process of consent. 5. 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). Exclusion Criteria: 1. Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study. 2. A WOCBP who has had a positive urine or serum pregnancy test at the time of screening unless: 1. they are menopausal defined by not having a menstrual cycle within the last 12 consecutive months or 2. they have had a hysterectomy. 3. Known allergy to iodides or shellfish. 4. Inadequate organ function at time of screening as defined below: a. Hepatic 1. Total bilirubin \>2 x Institutional Upper Limit of Normal (IULN). Participants with a history of Gilbert's disease must have total bilirubin \<3mg/dL. 2. AST (SGOT) and ALT (SPGT) \>3 x IULN. 5. Currently incarcerated individuals
Contact & Investigator
Jason Newman, MD, FACS
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT07149207 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Squamous Cell Carcinoma Head and Neck Cancer (HNSCC). 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 NCT07149207 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 NCT07149207 currently recruiting?
Yes, NCT07149207 is actively recruiting participants. Contact the research team at hcc-clinical-trials@musc.edu for enrollment information.
Where is the NCT07149207 trial being conducted?
This trial is being conducted at Charleston, United States.
Who is sponsoring the NCT07149207 clinical trial?
NCT07149207 is sponsored by Medical University of South Carolina. The principal investigator is Jason Newman, MD, FACS at Medical University of South Carolina. The trial plans to enroll 30 participants.
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