TumorGlow Intraoperative Molecular Imaging (IMI)
ConditionTumor, Solid
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Indocyanine Green
DrugThe 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.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cohort 1: Determine the safety of indocyanine green (all tumor types combined)
Type, frequency, severity, and attribution of AEs/SAEs (all tumor types combined).
Time frame
Up to 5 days2
Cohort 1: Identify optimal dosing of indocyanine green before surgery, and camera combination (tumor type-specific)
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.
Time frame
Up to 5 days3
Cohort 1: Identify optimal timing of indocyanine green before surgery, and camera combination (tumor type-specific)
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.
Time frame
Up to 5 days4
Cohort 2: Determine the sensitivity and specificity of indocyanine green (tumor type-specific)
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)
Time frame
Up to 5 daysSecondary outcomes
1
Cohort 1: Provide preliminary estimates of the sensitivity and specificity of indocyanine green (or TumorGlow) for identifying cancerous areas (tumor type-specific)
Nodule/lesion-level and subject-level sensitivity and specificity of indocyanine green (or TumorGlow) for identifying cancerous areas (tumor type-specific).
Time frame
Up to 5 days2
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)
Clinically Significant Event (CSE) rate (tumor type-specific).
Time frame
Up to 5 days3
Cohort 2: Confirm the safety of indocyanine green (all tumor types combined)
Type, frequency, severity, and attribution of AEs/SAEs (all tumor types combined).
Time frame
Up to 5 daysSponsors and contacts
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Source ClinicalTrials.gov