Using TumorGlow for imaging solid tumors during surgery
A Study to Evaluate the Safety and Efficacy of Indocyanine Green for Intraoperative Molecular Imaging of Solid Tumors (TumorGlow™)
This study is testing a special dye to see if it can help doctors see solid tumors better during surgery, so they can remove more cancer and improve patient outcomes.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04723810 on ClinicalTrials.gov |
What this trial studies
This Phase 1/2 study evaluates the safety and efficacy of using indocyanine green for intraoperative molecular imaging in patients with solid tumors or diseased tissue. The trial focuses on individuals who are surgical candidates and have tumors that are presumed to be resectable but at risk for recurrence. By enhancing the visualization of tumors during surgery, the study aims to improve surgical outcomes and reduce the likelihood of leaving residual cancerous tissue behind.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with solid tumors or diseased tissue that are resectable and at risk for recurrence.
Not a fit: Patients who are unable to provide informed consent or have uncontrolled hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective tumor resections and improved patient outcomes in cancer surgery.
How similar studies have performed: Other studies using intraoperative imaging techniques have shown promise, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Azra Din
- Email: azra.din@pennmedicine.upenn.edu
- Phone: 215-615-7980
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.