NCT05746104

Brief Summary

The study is being conducted to determine if a same-day, low-dose intravenous (into a vein) injection of indocyanine green (ICG) (FDA-approved dye) being detected by using an imaging system can be a useful tool in identifying and differentiating tumor tissue from normal tissues.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P75+ for phase_1

Timeline
9mo left

Started Mar 2023

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress80%
Mar 2023Feb 2027

First Submitted

Initial submission to the registry

February 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 27, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 31, 2023

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2027

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

3.9 years

First QC Date

February 17, 2023

Last Update Submit

January 21, 2026

Conditions

Nervous System Tumor

Outcome Measures

Primary Outcomes (3)

  • Tumor NIR Signal Compared to Background Brain Normal Signal (SBR)

    SBR analysis will be stratified by histology, and the dosing and timing flowchart will be used to achieve optimal SBR.

    Surgery

  • NIR Efficiency

    After examining the "equivocal tissue" with white light and NIR imaging, a per person success will be recorded, if least one additional specimen is resected using NIR. NIR will be considered efficacious, if significantly more than 10% of patients meet the success criteria. Each histology will be tested separately.

    Surgery

  • NIR True Positive Rate

    Of the additionally resected specimens using NIR, we will find the true positive rate based on pathology. The entire sample will be evaluated jointly; then, each histology will be evaluated separately as there may be multiple specimens per patient surgery. NIR will be considered efficacious if the true positive rate is significantly greater than 50%.

    Surgery

Secondary Outcomes (6)

  • Safety and Toxicity

    Surgery

  • Association Between Resection Decision and Pathology

    Surgery

  • Sensitivity

    Surgery

  • Specificity

    Surgery

  • Positive Predictive Value

    Surgery

  • +1 more secondary outcomes

Study Arms (1)

SWIG Arm

EXPERIMENTAL

This is the only arm for the study and will be experimental. All patients will receive the appropriate dosage of the study drug, which will then be used for visualization of the tumor intraoperatively.

Drug: Administration of Indocyanine Green (ICG) and Visualization of Tumor

Interventions

Administration of Indocyanine Green (ICG) and Visualization of TumorDRUG

A single dose of the study drug, ICG, of less than 2 mg/kg will be administered on the day of surgery. The visualization of second window ICG for tumor will be performed approximately one to four hours after administration, depending on how long it takes for the neurosurgeon to get through the skin/skull or lamina/dura to the tumor.

SWIG 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 nervous system tumor presumed to be resectable and at risk for local recurrence on pre-operative assessment
  • Good operative candidates, as determined by the treating physician and multidisciplinary team
  • Subjects capable of giving informed consent

You may not qualify if:

  • Pregnant women, as determined by urinary or serum beta hCG within 48 hours of surgery
  • Subjects with a history of iodide allergies
  • Vulnerable patient populations
  • Patients unable to participate in the consent process
  • Patients with history of uncontrolled HTN (requiring ER admission or ≥ 3 BP medications)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Nervous System Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsNervous System Diseases

Study Design

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

Study Record Dates

First Submitted

February 17, 2023

First Posted

February 27, 2023

Study Start

March 31, 2023

Primary Completion (Estimated)

February 15, 2027

Study Completion (Estimated)

February 15, 2027

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)