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NCT Number: NCT04723810

TumorGlow Intraoperative Molecular Imaging (IMI)

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.

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Key information

Conditions

Tumor, Solid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indocyanine green

Drug

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 outcomes

  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 outcomes

  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).

Study contacts

Contact information is provided by the study sponsor or research team.

Azra Din

CONTACT

[email protected]

215-615-7980

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

A Study to Evaluate the Safety and Efficacy of Indocyanine Green for Intraoperative Molecular Imaging of Solid Tumors (TumorGlow™)

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 26, 2021
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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