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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICG Arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Indocyanine Green (ICG) | Drug |
| ||
| Intraoperative near-infrared (NIR) |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity (SBR) | sensitivity of delayed, high dose indocyanine green (second window ICG), as measured by the signal-to-background ratio (SBR) | 72 hours |
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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
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| Name | Affiliation | Role |
|---|---|---|
| John Lee, MD | Abramson Cancer Center at Penn Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32514886 | Derived | Cho SS, Sheikh S, Teng CW, Georges J, Yang AI, De Ravin E, Buch L, Li C, Singh Y, Appelt D, Delikatny EJ, Petersson EJ, Tsourkas A, Dorsey J, Singhal S, Lee JYK. Evaluation of Diagnostic Accuracy Following the Coadministration of Delta-Aminolevulinic Acid and Second Window Indocyanine Green in Rodent and Human Glioblastomas. Mol Imaging Biol. 2020 Oct;22(5):1266-1279. doi: 10.1007/s11307-020-01504-w. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity (SBR) | sensitivity of delayed, high dose indocyanine green (second window ICG), as measured by the signal-to-background ratio (SBR) | Posted | Mean | Standard Deviation | ratio | 72 hours |
|
72 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Cardiac disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IV Site Reactions | Skin and subcutaneous tissue disorders | Systematic Assessment | 4 patients experienced IV site reactions during infusion. No treatment was deemed necessary and patients recovered upon observation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marie Kerr, Project Manager | University of Pennsylvania | 215-829-6720 | marie.kerr@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 15, 2019 | Sep 30, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 19, 2019 | Sep 30, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 118 |
| 336 |
| 3 |
| 336 |
| 13 |
| 336 |
|
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | 1 patient experienced respiratory distress during infusion and infusion was discontinued. |
|
|
| Hypertension | Cardiac disorders | Systematic Assessment | 3 patients experienced hypertension during infusion. Infusion was stopped for 1 patient. Infusion was slowed and completed for 1 patient. No action was taken for 1 patient. Hypertension resolved for all 3 patients upon observation. |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | 1 patient experienced hypoxia post-infusion. No treatment was deemed necessary. O2 levels recovered in time upon observation. |
|
| Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment | 2 patients experienced itching during infusion. Both patients received Benadryl, after which the itching resolved. |
|
| Hives | Skin and subcutaneous tissue disorders | Systematic Assessment | 1 patient experienced hives during infusion. The patient received Benadryl, after which the hives resolved. |
|
| Foot Drop | Musculoskeletal and connective tissue disorders | Systematic Assessment | 1 patient experienced foot drop, presumed secondary to brain tumor. AE was determined to be unrelated and unexpected by the study investigator. |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment | 1 patient reported nausea during infusion. Infusion was discontinued and the symptoms resolved. |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment | 1 patient began to vomit during infusion. Infusion was discontinued and the symptoms resolved. |
|
| Unilateral Upper Extremity Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | 2 patients reported upper extremity pain on the side of the IV placement and infusion. Infusion was discontinued for 1 patient and symptoms resolved. No action was taken for 1 patient and symptoms resolved upon observation. |
|
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