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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm trial | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine Green (ICG) | Drug | Dose: 5 mg/kg IV injection prior to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From time of surgery until final pathology results are available (about 2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From surgery until final pathology results are available (about 2 weeks) |
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Inclusion Criteria:
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:
Known allergy to iodides or shellfish.
Inadequate organ function at time of screening as defined below:
a. Hepatic
Currently incarcerated individuals
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| HCC Clinical Trials Office | Contact | 843-792-9321 | hcc-clinical-trials@musc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jason Newman, MD, FACS | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina Hollings Cancer Center | Recruiting | Charleston | South Carolina | 29425 | United States |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D009369 | Neoplasms |
| D000072662 | Margins of Excision |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| 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. | From surgery until final pathology results are available (about 2 weeks). |
| D009370 | Neoplasms by Histologic Type |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |