TumorGlow Intraoperative Molecular Imaging (IMI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Indocyanine Green.
- Who it may be relevant to
- Registry conditions: Tumor, Solid. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Study to Evaluate the Safety and Efficacy of Indocyanine Green for Intraoperative Molecular Imaging of Solid Tumors (TumorGlow™)
Overview
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
- Drug Indocyanine 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.
Primary outcome measures
- Cohort 1: Determine the safety of indocyanine green (all tumor types combined) [Time frame: Up to 5 days]
- Cohort 1: Identify optimal dosing of indocyanine green before surgery, and camera combination (tumor type-specific) [Time frame: Up to 5 days]
- Cohort 1: Identify optimal timing of indocyanine green before surgery, and camera combination (tumor type-specific) [Time frame: Up to 5 days]
- Cohort 2: Determine the sensitivity and specificity of indocyanine green (tumor type-specific) [Time frame: Up to 5 days]
- 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) [Time frame: Up to 5 days]
Secondary outcome measures (3)
- Cohort 1: Provide preliminary estimates of the sensitivity and specificity of indocyanine green (or TumorGlow) for identifying cancerous areas (tumor type-specific) [Time frame: Up to 5 days]
- 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) [Time frame: Up to 5 days]
- Cohort 2: Confirm the safety of indocyanine green (all tumor types combined) [Time frame: Up to 5 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT04723810 · 844554