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

Glioma Clinical Trial

Official title:

IRDye800CW-BBN PET-NIRF in Lower Grade Glioma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03407781
• Other study ID #: BTHospital-N-008
• Secondary ID: ZIAEB000073
• Status: Recruiting
• Phase: Early Phase 1
• First received: January 16, 2018
• Last updated: January 16, 2018
• Start date: January 1, 2016
• Est. completion date: December 30, 2018

Study information

• Verified date: January 2017
• Source: Beijing Tiantan Hospital
• Contact: Deling Li, MD
• Email: ttyyneuroli[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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/ NIFR study was designed to investigate the imaging guiding performance in lower grade glioma patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 µ?)

• 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

Related Conditions & MeSH terms

• Glioma

Intervention

Drug:
• 68Ga-BBN-IRDye800CW
PET/NIR fluorescent imaging-guided surgery

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Deling Li	Key laboratory of molecular imaging Chinese Academy of Sciences, National Institute for Biomedical Imaging and Bioengineering (NIBIB), Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardized uptake value of 68Ga-BBN-IRDye800CW in PET imaging of lower grade gliomas	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.	1 year
Secondary	The sensitivity and specificity of intraoperative IRDye800CW-BBN fluorescence	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	1 year