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Indocyanine Green for Central Nervous System Tumors

Primary Purpose

Suspected Central Nervous System Tumors

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Indocyanine Green (ICG)
Intraoperative near-infrared (NIR)
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Suspected Central Nervous System Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Abramson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ICG Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

Sensitivity (SBR)
sensitivity of delayed, high dose indocyanine green (second window ICG), as measured by the signal-to-background ratio (SBR)

Secondary Outcome Measures

Full Information

First Posted
March 14, 2016
Last Updated
September 30, 2021
Sponsor
Abramson Cancer Center at Penn Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02710240
Brief Title
Indocyanine Green for Central Nervous System Tumors
Official Title
A Pilot/Feasibility Study of Intraoperative Image-Guided Surgery of CNS Tumors With Indocyanine Green and MR Spectroscopic Imaging
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 10, 2015 (Actual)
Primary Completion Date
February 4, 2020 (Actual)
Study Completion Date
April 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suspected Central Nervous System Tumors

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
336 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ICG Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green (ICG)
Intervention Type
Radiation
Intervention Name(s)
Intraoperative near-infrared (NIR)
Primary Outcome Measure Information:
Title
Sensitivity (SBR)
Description
sensitivity of delayed, high dose indocyanine green (second window ICG), as measured by the signal-to-background ratio (SBR)
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Lee, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32514886
Citation
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.
Results Reference
derived

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Indocyanine Green for Central Nervous System Tumors

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