Clinical Trial · NCT02910804

IRDye800CW-BBN PET-NIRF Imaging Guiding Surgery in Patients With Glioblastoma

Overview

This is an open-label positron emission tomography/near infrared (PET/NIRF) study to investigate the imaging navigation performance and evaluation efficacy of dual modality imaging probe 68Ga-BBN-IRDye800CW in glioblastoma (GBM) patients. A single dose of 40μg/111-148 Mega-Becquerel (MBq) and 1.0 mg/ml 68Ga-BBN-IRDye800CW will be injected intravenously before the operation and intraoperative respectively. Visual and semiquantitative method will be used to assess the PET images and real-time margins localization for surgical navigation.

Sponsor

Beijing Cancer Hospital

Phase

Early Phase 1

Contacts

Deling Li, MD (CONTACT)

ttyyneuroli@126.com

Jingjing Zhang, MD. (CONTACT)

zhangjingjingtag@163.com

Nan Ji, MD (STUDY_DIRECTOR)

Zhaohui Zhu, MD. (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT02910804

Drug / Compound

BBN-IRDye800CW

Isotope(s):

Target(s):

GRPR

Ligand Class: Peptides

Chelator: NOTA

Eligibility

Inclusion

MRI imaging and/or pathological evidence of Newly Diagnosed or recurrence GBM

Exclusion

Severe liver or kidney disease with serum creatinine \> 3.0 mg/dl (270 μΜ)
Pregnancy or breast feeding
Severe allergy or hypersensitivity to IV radiographic contrast
Consisted of conditions of mental illness
Any hepatic enzyme level 5 times or more than normal upper limit
Claustrophobia to accept the PET/CT scanning