Clinical trial NCT04723810: TumorGlow Intraoperative Molecular Imaging (IMI)
Official title: A Study to Evaluate the Safety and Efficacy of Indocyanine Green for Intraoperative Molecular Imaging of Solid Tumors (TumorGlow™)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Tumor, Solid
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cohort 1: Determine the safety of indocyanine green (all tumor types combined)
timeFrame: Up to 5 days
measure: Cohort 1: Identify optimal dosing of indocyanine green before surgery, and camera combination (tumor type-specific)
timeFrame: Up to 5 days
measure: Cohort 1: Identify optimal timing of indocyanine green before surgery, and camera combination (tumor type-specific)
timeFrame: Up to 5 days
measure: Cohort 2: Determine the sensitivity and specificity of indocyanine green (tumor type-specific)
timeFrame: Up to 5 days
measure: 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)
timeFrame: Up to 5 days
Secondary outcomes:
measure: Cohort 1: Provide preliminary estimates of the sensitivity and specificity of indocyanine green (or TumorGlow) for identifying cancerous areas (tumor type-specific)
timeFrame: Up to 5 days
measure: 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)
timeFrame: Up to 5 days
measure: Cohort 2: Confirm the safety of indocyanine green (all tumor types combined)
timeFrame: Up to 5 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References: