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NCT04723810 | RECRUITING | Tumor, Solid

TumorGlow Intraoperative Molecular Imaging (IMI)
Sponsor:

University of Pennsylvania

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

Tumor, Solid

Intervention/treatment

Indocyanine Green

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 500 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : A Study to Evaluate the Safety and Efficacy of Indocyanine Green for Intraoperative Molecular Imaging of Solid Tumors (TumorGlow™)
Actual Study Start Date : 2024-08-14
Estimated Primary Completion Date : 2026-01-14
Estimated Study Completion Date : 2026-01-14

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
TumorGlow Intraoperative Molecular Imaging (IMI)

Location Details

NCT04723810

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How to Participate

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Locations

RECRUITING

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104