Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Indocyanine Green (ICG).
- Who it may be relevant to
- Registry conditions: Squamous Cell Carcinoma Head and Neck Cancer (HNSCC), Margin Assessment. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Indocyanine Green (ICG)
Dose: 5 mg/kg IV injection prior to surgery
Primary outcome measures
- Estimates of sensitivity and specificity using ICG. [Time frame: From time of surgery until final pathology results are available (about 2 weeks)]
Secondary outcome measures (2)
- 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).]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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:
a. 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Medical University of South Carolina Hollings Cancer Center — Charleston
Identifiers
NCT: NCT07149207 · 103776