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TumorGlow Intraoperative Molecular Imaging (IMI)

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ClinicalTrials.gov Identifier: NCT04723810
Recruitment Status : Not yet recruiting
First Posted : January 26, 2021
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tumor, Solid Drug: Indocyanine Green Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Study to Evaluate the Safety and Efficacy of Indocyanine Green for Intraoperative Molecular Imaging of Solid Tumors (TumorGlow™)
Estimated Study Start Date : February 15, 2022
Estimated Primary Completion Date : January 14, 2026
Estimated Study Completion Date : January 14, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
Patients scheduled to undergo surgical resection for the following cancers (known or suspected) that the safety and dosing/timing of indocyanine green has not been fully studied will be enrolled: glioma, breast cancer, colon cancer, rectal cancer, head and neck cancer, pulmonary metastasectomy (colorectal mets), thymoma, ovarian cancer, prostate cancer, renal cell carcinoma, thyroid cancer, parathyroid adenoma, mesothelioma, esophageal cancer, pancreas cancer, stomach cancer.
 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.
Experimental: Cohort 2
Patients scheduled to undergo surgical resection for the following cancers (known or suspected) that the safety and dosing/timing of indocyanine green has been fully studied will be enrolled: non-small cell lung cancer, metastatic sarcoma to the lung, brain meningioma.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Cohort 1: Determine the safety of indocyanine green (all tumor types combined) [ Time Frame: Up to 5 days ]
    Type, frequency, severity, and attribution of AEs/SAEs (all tumor types combined).

  2. Cohort 1: Identify optimal dosing of indocyanine green before surgery, and camera combination (tumor type-specific) [ Time Frame: 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.

  3. Cohort 1: Identify optimal timing of indocyanine green before surgery, and camera combination (tumor type-specific) [ Time Frame: 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.

  4. Cohort 2: Determine the sensitivity and specificity of indocyanine green (tumor type-specific) [ Time Frame: 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)

  5. 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 ]

    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 Outcome Measures :
  1. 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 ]
    Nodule/lesion-level and subject-level sensitivity and specificity of indocyanine green (or TumorGlow) for identifying cancerous areas (tumor type-specific).

  2. 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 ]
    Clinically Significant Event (CSE) rate (tumor type-specific).

  3. Cohort 2: Confirm the safety of indocyanine green (all tumor types combined) [ Time Frame: Up to 5 days ]
    Type, frequency, severity, and attribution of AEs/SAEs (all tumor types combined).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04723810


Contacts
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Contact: Azra Din 215-615-7980 azra.din@pennmedicine.upenn.edu

Sponsors and Collaborators
University of Pennsylvania
More Information
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04723810    
Other Study ID Numbers: 844554
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No