Tumor, Solid
Conditions
Brief summary
This is a Phase 1/2 study in patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and at risk for recurrence on pre-operative assessment who are considered to be good surgical candidates to evaluate the safety and efficacy of the image-guided surgery using indocyanine green for intramolecular imaging of solid tumors.
Interventions
DRUGIndocyanine Green
The investigational drug is indocyanine green, single dose between 1-5 mg/kg diluted into sterile water for intravenous (IV) injection up to 5 days prior to resection surgery. The actual dose and timing from dose to imaging will be determined based on tumor type.
Sponsors
University of Pennsylvania
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients 18 years of age or older. * Patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and at risk for recurrence on pre-operative assessment. * Good operative candidate as determined by the treating physician and/or multidisciplinary team. * Subject capable of giving informed consent.
Exclusion criteria
* Subject unable to participate in the consent process. * Vulnerable population including pregnant women, prisoners, and children. * History of uncontrolled hypertension (e.g., history of an ER admission for hypertensive crisis or ≥ 3 blood pressure medications) * Patients with a self-reported history of iodide allergies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1: Identify optimal timing of indocyanine green before surgery, and camera combination (tumor type-specific) | Up to 5 days | Timing of indocyanine green, and camera combination with the highest tumor-to-background ratio (TBR) (tumor type-specific). The minimum acceptable TBR value is 2. |
| Cohort 1: Determine the safety of indocyanine green (all tumor types combined) | Up to 5 days | Type, frequency, severity, and attribution of AEs/SAEs (all tumor types combined). |
| Cohort 1: Identify optimal dosing of indocyanine green before surgery, and camera combination (tumor type-specific) | Up to 5 days | Dosing of indocyanine green, and camera combination with the highest tumor-to-background ratio (TBR) (tumor type-specific). The minimum acceptable TBR value is 2. |
| Cohort 2: Determine the sensitivity and specificity of indocyanine green (tumor type-specific) | Up to 5 days | Nodule/lesion-level and subject-level sensitivity and specificity of TumorGlow (tumor type-specific). * Sensitivity of indocyanine green = TP/(TP+FN) = (# that fluoresce and are cancer)/(# that are cancer) * Specificity of indocyanine green = TN/(TN+FP) = (# that not cancer and do not fluoresce)/(# that are not cancer) |
| Cohort 2: Confirm the efficacy of indocyanine green used with Near Infrared (NIR) fluorescent imaging as measured by Clinically Significant Event (CSE) rate (tumor type-specific) | Up to 5 days | Clinically Significant Event (CSE) rate (tumor type-specific). A CSE includes any of the following event: * One or more primary nodule (cancerous or non-cancerous) not detected under normal light and/or palpation but is detected by imaging, * One or more cancerous synchronous lesion not detected under normal light and/or palpation but is detected by imaging, * The identification of a cancer positive margin that fluoresces within (less than or equal to) 5 mm of the surgical margin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cohort 1: Provide preliminary estimates of the sensitivity and specificity of indocyanine green (or TumorGlow) for identifying cancerous areas (tumor type-specific) | Up to 5 days | Nodule/lesion-level and subject-level sensitivity and specificity of indocyanine green (or TumorGlow) for identifying cancerous areas (tumor type-specific). |
| Cohort 1: Provide preliminary estimate of the efficacy of indocyanine green for locating additional cancers and missed surgical margins as measured by CSE rate (tumor type-specific) | Up to 5 days | Clinically Significant Event (CSE) rate (tumor type-specific). |
| Cohort 2: Confirm the safety of indocyanine green (all tumor types combined) | Up to 5 days | Type, frequency, severity, and attribution of AEs/SAEs (all tumor types combined). |
Countries
United States
Contacts
CONTACTAzra Din
Outcome results
None listed