By InvitationPhase 1

Second Window Indocyanine Green for All Nervous System Tumors

United States105 participantsStarted 2023-03-31

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

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

What they're measuring

Tumor NIR Signal Compared to Background Brain Normal Signal (SBR)

Timeframe: Surgery

NIR Efficiency

Timeframe: Surgery

NIR True Positive Rate

Timeframe: Surgery

Trial details

NCT IDNCT05746104

SponsorAbramson Cancer Center at Penn Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02-15

View on ClinicalTrials.gov More Nervous System Tumor trials