Margin Assessment, Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)
Conditions
Keywords
Cancer, surgical margins, head and neck cancer, mucosal squamous cell cancer
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.
Interventions
DRUGIndocyanine Green (ICG)
Dose: 5 mg/kg IV injection prior to surgery
Sponsors
Medical University of South Carolina
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimates of sensitivity and specificity using ICG. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and proportion of samples for which visualization is altered using dimension. | From surgery until final pathology results are available (about 2 weeks) | 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). |
| Estimates of sensitivity and specificity using white light visualization. | From surgery until final pathology results are available (about 2 weeks). | Sensitivity and specificity point and interval estimates of white light visualization relative to pathology gold standard will be constructed as described for ICG. |
Countries
United States
Contacts
CONTACTHCC Clinical Trials Office
PRINCIPAL_INVESTIGATORJason Newman, MD, FACS
Medical University of South Carolina
Outcome results
None listed