Health TrialsbyHealthPanel

Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures

ConditionBrain Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-25
SponsorStanford University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects with suspected brain tumors undergoing surgical removal as their standard of care will be eligible. These may include subjects status post chemotherapy and/or radiation or subjects who have undergone diagnostic biopsy for their original diagnosis and are felt to be candidates for resection.

Subjects must be eligible for resection as determined by the operating surgeon.

Planned standard of care surgery

Subject age 6 months to 25 years

Disqualifiers

Received an investigational drug within 30 days prior to first dose of Panitumumab IRDye800

Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment

History of infusion reactions to monoclonal antibody therapies

Pregnant or breastfeeding

Trial design

Design model

Sequential

Treatments tested in this trial

  • Panitumumab-IRDye800

    Drug

    Panitumumab-IRDye800 is an imaging agent prepared as a drug-dye compound from panitumumab (Vectibix), a fully-humanized IgG2 monoclonal anti-epidermal growth factor receptor (EGFR) antibody, and IRDye800CW dye. Panitumumab-IRDye800 delivered intravenous (IV).

  • Pinpoint-IR9000 endoscopic/handheld device

    Device

    Novadaq intraoperative camera capable of exciting and detecting near infrared (NIR) dyes. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the "back table" in the surgery suite (ex-vivo).

  • Explorer Air camera

    Device

    Surgvision intraoperative camera. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the "back table" in the surgery suite (ex-vivo).

  • PDE-NEO-II

    Device

    Hamamatsu Photonics KK intraoperative camera. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the "back table" in the surgery suite (ex-vivo).

Treatment groups

12 Participants
are divided into 4 treatment groups
Group A: Cohort 1-0.006 Panitumumab-IRDye800Experimental treatment 4 interventions
Group B: Cohort 2-0.25 Panitumumab-IRDye800Experimental treatment 4 interventions
Group C: Cohort 3-0.50 Panitumumab-IRDye800Experimental treatment 4 interventions
Group D: Cohort 4-1.0 Panitumumab-IRDye800Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Toxicities (related adverse events)

Adverse events related to the agent or procedure are considered toxicities, and is assessed as the number of Grade 2 or higher adverse events which have been determined to be clinically-significant and definitely, probably, or possibly-related to the study treatment or procedure. The outcome is reported by dose treatment group (cohort) as a number without dispersion.

Time frame
30 days

Secondary outcomes

1

Panitumumab-IRDye800 Fluorescence Intensity

Dosing of panitumumab-IRDye800 in the study participants will be assessed on the basis of fluorescence intensity, determined as the ratio of fluorescence intensity in tumor tissue to that of normal tissue. This is known as the tumor-to-background ratio (TBR). The outcome will be reported by dose treatment group (cohort) as the mean TBR with standard deviation.

Time frame
5 days
2

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

The merit of Panitumumab-IRDye800 to identify pediatric tumors during surgery will be assessed as sensitivity, specificity, positive predictive value (PPV), and negative predictive value (PPV), based on the actual histopathological diagnosis for the excised lesions. * Sensitivity is the "true positive rate" (by histopathology), expressed as a proportion (ratio) * Specificity is the "true negative rate," expressed as a proportion * Positive predictive value (PPV) is the proportion of tumor-positive samples that were actually cancer; * Negative predictive value (NPV) is the proportion of tumor-negative samples that were not cancer. Per protocol, the analysis is only conducted for those participants who were treated with the optimal dose level. Higher values indicate greater merit. The outcome will be reported per protocol for the optimal dose level as the sensitivity; specificity; PPV; and NPV, with 95% confidence interval.

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Source ClinicalTrials.gov
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