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Indocyanine Green Dye for Nervous System Cancer

Phase 1

Recruiting

Research Sponsored by Abramson Cancer Center of the University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up surgery

Awards & highlights

Study Summary

This trial tests if a dye injection can help doctors find and tell the difference between cancer and normal tissue.

Who is the study for?

This trial is for adults over 18 with nervous system tumors that can be surgically removed and are at risk of coming back. Candidates must be in good enough health for surgery as judged by their doctors, and able to give informed consent. Pregnant women, those allergic to iodide, patients unable to consent, with uncontrolled high blood pressure or from vulnerable populations cannot join.Check my eligibility

What is being tested?

The study tests if a low-dose indocyanine green (ICG) dye injected into the vein on the same day as surgery helps distinguish tumor tissue from normal tissue during operations using a special imaging system.See study design

What are the potential side effects?

Potential side effects may include reactions related to ICG such as nausea or an allergic reaction. However, since ICG is FDA-approved and used at low doses, significant side effects are not commonly expected.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

NIR Efficiency

NIR True Positive Rate

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

Secondary outcome measures

Association Between Resection Decision and Pathology

Negative Predictive Value

Positive Predictive Value

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: SWIG ArmExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor

359 Previous Clinical Trials

104,939 Total Patients Enrolled

Abramson Cancer Center at Penn MedicineLead Sponsor

387 Previous Clinical Trials

145,539 Total Patients Enrolled

Media Library

SWIG Arm Clinical Trial Eligibility Overview. Trial Name: NCT05746104 — Phase 1

Neurofibromatosis Research Study Groups: SWIG Arm

Neurofibromatosis Clinical Trial 2023: SWIG Arm Highlights & Side Effects. Trial Name: NCT05746104 — Phase 1

SWIG Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05746104 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the SWIG Arm device obtained clearance from regulatory bodies?

"Our internal assessment of SWIG Arm's safety levels is 1, given that this Phase 1 trial has only limited evidence for both efficacy and security."

Answered by AI

What is the aggregate amount of individuals enrolled in this experiment?

"Affirmative. The information released on clinicaltrials.gov reveals that this research study is currently recruiting participants, with the initial posting on March 31st 2023 and last updated on June 27th 2023. A total of 105 individuals are sought from a single location for the trial."

Answered by AI

Are there any accessible openings for participants in this research endeavor?

"Yes, according to clinicaltrials.gov information, this research project is presently recruiting participants. It was initially made available on March 31st 2023 and was most recently updated on June 27th of the same year. The trial seeks 105 volunteers from a single site."

Answered by AI

What are the objectives of this research endeavor?

"The principal aim of this medical research, with observations conducted for the duration of surgery, is to identify true positive rates. Other metrics evaluated include safety and toxicity by assessing vital signs as well as any adverse events reported or seen. Association between excision choice and pathology will be also gauged across all equivocal tissues stratified by their histology. Finally, sensitivity shall be estimated utilizing a ROC curve along side its respective confidence intervals."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Second Window Indocyanine Green for All Nervous System Tumors

2023. "Second Window Indocyanine Green for All Nervous System Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05746104.

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