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Panitumumab-IRDye800 for Brain Tumor

Phase 1 & 2

Waitlist Available

Led By Gerald Grant, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Subject age 6 months to 25 years

Planned standard of care surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Study Summary

This trial is testing if a dye called panitumumab-IRDye800 is safe to use in children during brain surgery to remove suspected tumors.

Who is the study for?

This trial is for children and young adults aged 6 months to 25 years with suspected brain tumors who are undergoing surgery. They should have a life expectancy over 12 weeks and be fit for tumor removal as per the surgeon's assessment. Pregnant or breastfeeding individuals, those with certain heart risks, abnormal lab values, recent investigational drug use, severe liver disease, or history of bad reactions to monoclonal antibodies cannot join.Check my eligibility

What is being tested?

The study tests the safety of Panitumumab-IRDye800 during pediatric brain surgeries. This involves using special devices like Pinpoint-IR9000 and Explorer Air cameras to detect tumors in real-time during operations.See study design

What are the potential side effects?

Potential side effects may include allergic reactions similar to other monoclonal antibody therapies. Since this is a safety assessment trial, detailed side effects will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 6 months and 25 years old.

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I am scheduled for a standard surgery recommended by my doctor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Toxicities (related adverse events)

Secondary outcome measures

Panitumumab-IRDye800 Fluorescence Intensity

Tumor-to-background Ratio (TBR) Sensitivity and Specificity for Optimal Dose Level

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4-1.0 Panitumumab-IRDye800Experimental Treatment4 Interventions

Dose: 1.0 (with max cap dose 50 mg) Panitumumab-IRDye800 (mg/kg)

Group II: Cohort 3-0.50 Panitumumab-IRDye800Experimental Treatment4 Interventions

Dose: 0.50 Panitumumab-IRDye800 (mg/kg)

Group III: Cohort 2-0.25 Panitumumab-IRDye800Experimental Treatment4 Interventions

Dose: 0.25 Panitumumab-IRDye800 (mg/kg)

Group IV: Cohort 1-0.006 Panitumumab-IRDye800Experimental Treatment4 Interventions

Dose: 0.006 Panitumumab-IRDye800 (mg/kg)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Explorer Air camera

2019

Completed Phase 1

~20

Panitumumab-IRDye800

2019

Completed Phase 2

~20

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,387 Previous Clinical Trials

17,334,038 Total Patients Enrolled

Gerald Grant, MDPrincipal InvestigatorStanford University

Media Library

Panitumumab-IRDye800 Clinical Trial Eligibility Overview. Trial Name: NCT04085887 — Phase 1 & 2

Brain Tumor Research Study Groups: Cohort 2-0.25 Panitumumab-IRDye800, Cohort 3-0.50 Panitumumab-IRDye800, Cohort 4-1.0 Panitumumab-IRDye800, Cohort 1-0.006 Panitumumab-IRDye800

Brain Tumor Clinical Trial 2023: Panitumumab-IRDye800 Highlights & Side Effects. Trial Name: NCT04085887 — Phase 1 & 2

Panitumumab-IRDye800 2023 Treatment Timeline for Medical Study. Trial Name: NCT04085887 — Phase 1 & 2

Frequently Asked Questions

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

Are people who are over 25 years old currently being recruited for this trial?

"Eligibility for this clinical trial is restricted to patients that are between 6 months and 25 years old."

Answered by AI

Is this research innovative in any way?

"To date, there have been 38 clinical trials involving Panitumumab-IRDye800 in 151 cities across 16 countries. The first trial, conducted in 2011, was sponsored by Amgen. It completed Phase 2 drug approval and involved 75 patients. In the decade since 2011, 101 more trials have been completed."

Answered by AI

Are researchers still enrolling people for this experiment?

"According to the listing on clinicaltrials.gov, this trial is not recruiting patients. The study was first posted on September 1st, 2020 and was last updated on June 10th, 2020. Despite this study not being active, there are 2,553 other studies that are currently recruiting patients."

Answered by AI

Who does this research pertain to?

"This study is recruiting paediatric patients that have neoplasms in their brain. The age limit for participants is 6 months to 25 years old. They are hoping to enroll around 12 patients in total."

Answered by AI

Are there any other groundbreaking studies that have utilized Panitumumab-IRDye800?

"There are 38 different ongoing clinical trials researching the efficacy of Panitumumab-IRDye800 with 3 of those trials having reached Phase 3. The majority of these medical trials are based in Nagoya-shi, Aichi; however, there are 600 total locations running these types of trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures

2024. "Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04085887.

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