Suspected Central Nervous System Tumors
Conditions
Brief summary
This study is a single center, open-label, two-part study to assess image guided surgery of intramolecular imaging in nervous system tumors. Subjects with a diagnosis of a resectable nervous system tumor who are at risk of recurrence are included. The primary goal is to observe what tissues fluoresce in the OR, and then to identify if that tissue is cancerous/tumor or normal when the histopathology is performed.
Interventions
DRUGIndocyanine Green (ICG)
RADIATIONIntraoperative near-infrared (NIR)
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult patients 18 years of age and older Patients presenting with a CNS tumor presumed to be resectable and are at risk for local recurrence on pre-operative assessment Good operative candidate as determined by the treating physician and multidisciplinary team Subject capable of giving informed consent and participating in the process of consent
Exclusion criteria
Pregnant women as determined by urinary or serum beta hCG within 72 hours of surgery Subjects with a history of iodide allergies Vulnerable patient populations Patients unable to participate in the consent process (children and neonates) Patients with non-MRI compatible implanted metallic foreign bodies Patients who due to severe claustrophobia cannot tolerate MRI scanning Patients with a known allergy or hypersensitivity to MRI contrast agents including gadolinium
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity (SBR) | 72 hours | sensitivity of delayed, high dose indocyanine green (second window ICG), as measured by the signal-to-background ratio (SBR) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ICG Arm Subjects undergo indocyanine green injection within 72 hours prior to surgery. Permitting infusion time within 72 hours of operation is believed to be adequate for tissue glow/surgical visualization. Alternately, patients may receive 25 mg of indocyanine green during induction. Dose and time of administration will be determined by the neurosurgeon during surgical planning. This 25 mg dose of indocyanine green is similar to dosing for other intraoperative vascular visualization. | 336 |
| Total | 336 |
Baseline characteristics
| Characteristic | ICG Arm | — |
|---|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 14.49 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 336 Participants | — |
| Sex: Female, Male Female | 191 Participants | — |
| Sex: Female, Male Male | 145 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 118 / 336 |
| other Total, other adverse events | 13 / 336 |
| serious Total, serious adverse events | 3 / 336 |
Outcome results
Primary
Sensitivity (SBR)
sensitivity of delayed, high dose indocyanine green (second window ICG), as measured by the signal-to-background ratio (SBR)
Time frame: 72 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ICG Arm | Sensitivity (SBR) | 5.49 ratio | Standard Deviation 3.2 |