Skip to main content
OpenTrials
Completed

NCT Number: NCT03407781

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Tiantan Hospital

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

68Ga-BBN-IRDye800CW

Drug

PET/NIR fluorescent imaging-guided surgery

Other names: IRDye800CW-BBN

Primary outcomes

  1. Standardized uptake value of 68Ga-BBN-IRDye800CW in PET imaging of lower grade gliomas

    Time frame: 1 year

    The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in lower grade glioma will be measured.

Secondary outcomes

  1. The sensitivity and specificity of intraoperative IRDye800CW-BBN fluorescence

    Time frame: 1 year

    The sensitivity and specificity of intraoperative IRDye800CW-BBN fluorescence, and the preoperative PET and MRI imaging indicator for IRDye800CW-BBN fluorescence imaging in lower grade gliomas

Sponsors and collaborators

Lead sponsor

Deling Li

Other

Collaborators

  • Chinese Academy of Sciences
  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)
  • Peking Union Medical College Hospital

Registry information

Official study title

IRDye800CW-BBN PET-NIRF in Lower Grade Glioma

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 23, 2018
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.