NCT02710240

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
336

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 2, 2020

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

October 27, 2021

Completed
Last Updated

October 27, 2021

Status Verified

September 1, 2021

Enrollment Period

4.7 years

First QC Date

March 14, 2016

Results QC Date

September 2, 2021

Last Update Submit

September 30, 2021

Conditions

Suspected Central Nervous System Tumors

Outcome Measures

Primary Outcomes (1)

  • Sensitivity (SBR)

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

    72 hours

Study Arms (1)

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.

Drug: Indocyanine Green (ICG)Radiation: Intraoperative near-infrared (NIR)

Interventions

Indocyanine Green (ICG)DRUG
ICG Arm
Intraoperative near-infrared (NIR)RADIATION
ICG Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 32514886DERIVED

MeSH Terms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Marie Kerr, Project Manager
Organization
University of Pennsylvania
marie.kerr@pennmedicine.upenn.edu
215-829-6720

Study Officials

  • John Lee, MD

    Abramson Cancer Center at Penn Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2016

First Posted

March 16, 2016

Study Start

June 10, 2015

Primary Completion

February 4, 2020

Study Completion

April 2, 2020

Last Updated

October 27, 2021

Results First Posted

October 27, 2021

Record last verified: 2021-09

Locations

US(1)