Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures

Conditions

• Brain Tumor

Eligibility Criteria

Sex

ALL

Age

6 Months - 25 Years

Healthy Volunteers

Not accepted

Interventions

• 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).

Study Details

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

Key Dates

Start date

Apr 30, 2026

Status verified

Mar 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

12 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Cohort 1-0.006 Panitumumab-IRDye800
  Dose: 0.006 Panitumumab-IRDye800 (mg/kg)
• Experimental: Cohort 2-0.25 Panitumumab-IRDye800
  Dose: 0.25 Panitumumab-IRDye800 (mg/kg)
• Experimental: Cohort 3-0.50 Panitumumab-IRDye800
  Dose: 0.50 Panitumumab-IRDye800 (mg/kg)
• Experimental: Cohort 4-1.0 Panitumumab-IRDye800
  Dose: 1.0 (with max cap dose 50 mg) Panitumumab-IRDye800 (mg/kg)

Primary Outcome Measure

Toxicities (related adverse events) [ Time Frame: 30 days ]

Central Contacts

• Nancy Sweeters
  650-721-4074
  [email protected]

Locations (1)

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