IRDye800CW-BBN PET-NIRF Imaging Guiding Surgery in Patients With Lower Grade Glioma

Deling Li

Status and phase: Completed; Phase 1

Conditions: Glioma

Treatments: Drug: 68Ga-BBN-IRDye800CW

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03407781

BTHospital-N-008

ZIAEB000073 (U.S. NIH Grant/Contract)

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 patients with lower grade glioma. A single dose of 40μg/111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN and 1.0- or 2.0- mg/ml IRDye800CW-BBN 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

Lower grade gliomas (WHO grades II and III) are currently diffused disease with variability of tumor behaviors and of challenge to distinguish the margins in white-light microscope during the surgery. An integrated dual-modality approach combining preoperative positron emission tomography imaging with intraoperative optical guidance that target the same tumor biomarker would be of grade help to solve this problem. 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 glioma. For interests in clinical translation of GRPR targeting dual modality probe, an open label dual modality imaging PET/ NIRF study was designed to investigate the imaging guiding performance in lower grade glioma patients. To investigate whether the preoperative PET with BBN can predict the success of the fluorescence guided surgery with same peptide intraoperatively. The sensitivity, specificity and accuracy of fluorescence guided sampling intraoperatively according to the final pathology will be assessed as well.

Enrollment: 52 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must be able to provide a written informed consent
• suspected lower grade gliomas on contrast-enhanced MRI

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 or PET/MRI scanning
• Pregnancy or breast feeding

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

52 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 or 2.0 mg/ml BBN-IRDye800CW injected intravenously for near-infrared (NIR) fluorescent imaging-guided surgery.

Treatment:

Drug: 68Ga-BBN-IRDye800CW