NCT03407781

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

IRDye800CW-BBN PET-NIRF in Lower Grade Glioma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Deling Li · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Glioma

Interventions

Type	Name	Description
DRUG	68Ga-BBN-IRDye800CW	PET/NIR fluorescent imaging-guided surgery

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-08-17
• Completion: 2018-08-17
• First posted: 2018-01-23
• Last updated: 2024-08-06

Locations

1 site across 1 country: China