A Phase 1/2 interventional study of Image-Guided Surgery and Indocyanine Green Drug in Head and Neck Carcinoma, sponsored by Jonsson Comprehensive Cancer Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-17.
Sponsored by Jonsson Comprehensive Cancer Center · Phase 1/2, Interventional, and Treatment
This phase Ib/II trial studies the side effects of near-infrared image guided surgical resection with indocyanine green in treating patients with head and neck cancer. Near-infrared image guided surgical resection with indocyanine green may make it easier to find and remove tumors.
PRIMARY OBJECTIVES:
I. To determine the safety profile of high-dose optical dye, indocyanine green, in head and neck cancer surgical patients.
SECONDARY OBJECTIVES:
I. Determine the efficacy of high-dose indocyanine green to identify cancer compared to surrounding normal tissue (tumor to background ratio; TBR) in head and neck cancer resections.
OUTLINE:
Patients receive indocyanine green intravenously (IV) on day 0 and undergo near-infrared image guided surgical resection on day 1.
After completion of study treatment, patients are followed up for 14-30 days.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
Browse Head and Neck Neoplasms studies →Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.
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Exclusion Criteria:
Patients receive indocyanine green IV on day 0 and undergo near-infrared image guided surgical resection on day 1.
Procedure: Image-Guided Surgery · Drug: Indocyanine Green Drug
Undergo near-infrared image guided surgical resection
Given IV
Also known as: IC-GREEN, ICG Drug in solution
Safety related by type, incidence, severity, seriousness, and study treatment relatedness of adverse events
Adverse events will be tabulated by treatment group and will include the number of patients for whom the event occurred, the rate of occurrence, and the severity and relationship to study drug.
Time frame: Up to 30 days
Successful tumor fluorescence imaging data gathered for all patients included in the study
The effect of indocyanine green will be assessed by changes in tumor-to-background ratio (TBR). Tumor to background (TBR) data will be generated from still images collected throughout the procedure as previously described (Heath, Deep et al.). The presence of fluorescence in normal surrounding tissue will be correlated with fluorescence within the tumor mass. The linear relationship between fluorescence and tumor size will be computed as Spearman?s correlation coefficient. Continuous variable means (e.g., fluorescence intensity) will be compared to histological quantification of tumor as measured by the greatest dimension identified on the histopathological assessment.
Time frame: Up to 30 days
This study is withdrawn, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Jonsson Comprehensive Cancer Center