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

Capital Medical University

Status and phase: Unknown; Early Phase 1

Conditions: Glioblastoma

Treatments: Procedure: PET/NIR fluorescent imaging-guided surgery; Device: PET/NIRF; Drug: 68Ga-BBN-IRDye800CW

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02910804

ZIAEB000073 (U.S. NIH Grant/Contract)

BTHospital-N-005

Details and patient eligibility

About

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.

Full description

Non-invasive preoperative PET imaging evaluation and real-time fluorescence-guided surgery would be of great help in GBM patients. BBN, with the amino acid sequence of Gln-Trp-Ala-Val-Gly-His-Leu-Met-NH2, has been extensively used for the development of molecular probes for the imaging of gastrin-releasing peptide receptor (GRPR), a member of the G protein-coupled receptor family of bombesin receptors that over-expressed in various types of cancer cells including glioblastoma multiforme. For interests in clinical translation of GRPR targeting dual modality probe, an open label dual modality imaging PET/ NIFR study was designed to investigate the safety and imaging guiding performance of 68Ga-BBN-IRDye800CW in patients with GBM.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must be able to provide a written informed consent
• MRI imaging and/or pathological evidence of Newly Diagnosed or recurrence GBM

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

68Ga-BBN-IRDye800CW PET/NIRF

Experimental group

Description:

The patients were injected with 40μg/111-148 Mega-Becquerel (MBq) 68Ga-BBN-IRDye800CW in one dose intravenously and then underwent PET scan 30 min later before the operation and intraoperative 1.0 mg/ml BBN-IRDye800CW injected intravenously for near-infrared (NIR) fluorescent imaging-guided surgery.

Treatment:

Procedure: PET/NIR fluorescent imaging-guided surgery

Drug: 68Ga-BBN-IRDye800CW

Device: PET/NIRF