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Indocyanine Green for Central Nervous System Tumors

NCT ID: NCT02710240

Last Updated: 2021-10-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

336 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-10

Study Completion Date

2020-04-02

Brief Summary

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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.

Detailed Description

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Conditions

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Suspected Central Nervous System Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Indocyanine Green (ICG)

Intervention Type DRUG

Intraoperative near-infrared (NIR)

Intervention Type RADIATION

Interventions

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Indocyanine Green (ICG)

Intervention Type DRUG

Intraoperative near-infrared (NIR)

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Locations

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Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32514886 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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UPCC 09315

Identifier Type: -

Identifier Source: org_study_id