30 Participants NeededMy employer runs this trial

Panitumumab-IRDye800 for Brain Cancer

MB
NJ
Overseen ByNicole Jones
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and imaging capabilities of a new fluorescent agent, panitumumab-IRDye800, in patients with brain lesions scheduled for surgical removal. The treatment involves administering a single dose of the agent before surgery to enhance tumor visibility. Participants are divided into two groups: one receiving a 50 mg dose and the other a 100 mg dose. Eligible candidates have brain lesions requiring surgery and may have undergone previous chemotherapy or radiation. As an Early Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

Is there any evidence suggesting that panitumumab-IRDye800 is likely to be safe for humans?

Research has shown that panitumumab-IRDye800 is generally safe for patients with brain tumors. In one study involving 11 patients, researchers found no harmful side effects. Another study confirmed that this treatment helps surgeons see tumor cells more clearly and is safe at doses of 50 mg and 100 mg. These findings suggest that the treatment is well-tolerated and effective in improving tumor visibility during surgery.12345

Why are researchers excited about this trial's treatment?

Most treatments for brain cancer involve surgery, radiation, and chemotherapy. However, Panitumumab-IRDye800 is unique because it uses a fluorescent dye combined with an antibody to help surgeons see cancer cells more clearly during surgery. This approach aims to improve the precision of tumor removal, potentially leading to better outcomes for patients. By enhancing visualization, this treatment could reduce the likelihood of cancer cells being left behind, which is a common challenge with current surgical methods. Researchers are excited about this treatment as it represents a novel way to aid surgical procedures and possibly improve survival rates for brain cancer patients.

What evidence suggests that panitumumab-IRDye800 could be effective for brain cancer?

Research has shown that panitumumab-IRDye800 is a special dye that enhances tumor visibility during surgery. It targets a protein called EGFR, often abundant on certain cancer cells. Early studies demonstrated that this dye can make cancerous tissues more visible, potentially aiding surgeons in more effective tumor removal. In this trial, participants will receive either a 50 mg or 100 mg dose of panitumumab-IRDye800 before their standard-of-care neurosurgical resection. In trials with other cancers, such as pancreatic cancer, panitumumab-IRDye800 improved tumor visibility for surgeons. Its safety has been well-documented, making it a promising tool for surgeries involving brain tumors.678910

Who Is on the Research Team?

PM

Peter Morone, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults (18+) with brain tumors or lesions who are scheduled for surgical removal. Participants must have normal blood tests, not be pregnant if female, and be able to give consent themselves or through a healthcare decision maker.

Inclusion Criteria

I am 18 years old or older.
Women of childbearing potential must have a negative pregnancy test within 7 days of study drug administration
I am able and willing to sign a consent form for this study.
See 2 more

Exclusion Criteria

Baseline QTcF interval greater than 480 milliseconds
I am currently pregnant or breastfeeding.
I have had lung scarring or inflammation in the past.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-Surgery Treatment

Participants receive a single intravenous dose of panitumumab-IRDye800 (pan800) 1-5 days before neurosurgical resection

1-5 days
1 visit (in-person)

Surgery and Immediate Post-Infusion Monitoring

Participants undergo neurosurgical resection with intraoperative near-infrared fluorescence imaging and immediate post-infusion monitoring

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including postoperative assessments and a Day 15 follow-up contact

15 days post-infusion
1 visit (in-person), 1 contact (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Panitumumab-IRDye800

Trial Overview

The study is testing Panitumumab-IRDye800, a fluorescent imaging agent that targets EGFR, to see how well it helps surgeons detect brain tumors during surgery. The main focus is on safety and how clearly the dye highlights tumor tissue.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Study Arm - 50 mg pan800Experimental Treatment1 Intervention
Group II: Study Arm - 100 mg pan800Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eben Rosenthal

Lead Sponsor

Trials
9
Recruited
200+

Citations

Panitumumab-IRDye800 for Brain Tumors in Children

Now recruiting in Stanford, CA. Ages 6 Months – 25. This trial is looking for children and young adults who may have brain tumors and need surgery.…

Panitumumab-IRDye800 in Diagnosing Participants With ...

The phase I/II trial studies the side effects and best dose of panitumumab-IRDye800 in diagnosing participants with malignant glioma who undergo surgery.

Panitumumab-IRDye800 in Patients With Pancreatic Cancer ...

Panitumumab-IRDye800 may attach to tumor cells and make them more visible during surgery in patients with pancreatic cancer. Show more ...

Panitumumab-IRDye800 in Patients With Pancreatic ...

This phase I/II trial studies the side effects and best dose of panitumumab-IRDye800 and to see how well it works in finding cancer in patients ...

Panitumumab-IRDye800CW(Stanford University) - Drug ...

Our data indicate that FLT imaging is a promising approach for enhancing tumor contrast using an antibody-targeted NIR probe with a proven safety profile in ...

Optical Imaging Agent (Panitumumab-IRDye800) to Detect ...

Panitumumab IRDye800 may be safe, tolerable and when used with NIR imaging may help surgeons better distinguish tumor cells from normal brain tissue

EGFR-targeted intraoperative fluorescence imaging detects ...

Panitumumab-IRDye800 provided excellent tumor contrast and was safe at both doses. Smaller fragments of tumor could be detected at the 100 mg dose

Panitumumab-IRDye800 for Brain Cancer

Research has shown that panitumumab-IRDye800 is safe and effective for imaging brain tumors. In a study with 11 patients, no harmful side effects occurred,

Panitumumab-IRDye800 to Detect Pediatric Neoplasms ...

The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors ...

Panitumumab-IRDye800 in Diagnosing Participants With ...

The phase I/II trial studies the side effects and best dose of panitumumab-IRDye800 in diagnosing participants with malignant glioma who ...