Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnant or breastfeeding, or expecting to conceive within the projected duration of the study.
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.
Trial design
Design model
Single group
Treatments tested in this trial
Indocyanine Green (ICG)
DrugDose: 5 mg/kg IV injection prior to surgery
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Single arm trialExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From time of surgery until final pathology results are available (about 2 weeks)Secondary outcomes
1
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).
Time frame
From surgery until final pathology results are available (about 2 weeks)2
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.
Time frame
From surgery until final pathology results are available (about 2 weeks).Sponsors and contacts
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Source ClinicalTrials.gov