Second Window Indocyanine Green for All Nervous System Tumors

Study Purpose

The study is being conducted to determine if a same-day, low-dose intravenous (into a vein) injection of indocyanine green (ICG) (FDA-approved dye) being detected by using an imaging system can be a useful tool in identifying and differentiating tumor tissue from normal tissues.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Adult patients 18 years of age and older. 2. Patients presenting with a nervous system tumor presumed to be resectable and at risk for local recurrence on pre-operative assessment. 3. Good operative candidates, as determined by the treating physician and multidisciplinary team. 4. Subjects capable of giving informed consent.

Exclusion Criteria:

1. Pregnant women, as determined by urinary or serum beta hCG within 48 hours of surgery. 2. Subjects with a history of iodide allergies. 3. Vulnerable patient populations. 4. Patients unable to participate in the consent process. 5. Patients with history of uncontrolled HTN (requiring ER admission or ≥ 3 BP medications)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05746104
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Abramson Cancer Center at Penn Medicine
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Nervous System Tumor

Arms & Interventions

Arms

Experimental: SWIG Arm

This is the only arm for the study and will be experimental. All patients will receive the appropriate dosage of the study drug, which will then be used for visualization of the tumor intraoperatively.

Interventions

Drug: - Administration of Indocyanine Green (ICG) and Visualization of Tumor

A single dose of the study drug, ICG, of less than 2 mg/kg will be administered on the day of surgery. The visualization of second window ICG for tumor will be performed approximately one to four hours after administration, depending on how long it takes for the neurosurgeon to get through the skin/skull or lamina/dura to the tumor.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Pennsylvania Hospital, Philadelphia, Pennsylvania

Status

Recruiting

Address

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107

Site Contact

John Y Lee, MD

[email protected]

215-829-6720

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