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

NCT03407781 | Completed Phase 1

• 2 other identifiers: BTHospital-N-008ZIAEB000073
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioma

Keywords

fluorescence guided surgery; dual-modality imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The sensitivity and specificity of intraoperative IRDye800CW-BBN fluorescence

  1 year

Study Arms (1)

68Ga-BBN-IRDye800CW PET/NIRF

EXPERIMENTAL

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.

Drug: 68Ga-BBN-IRDye800CW

Interventions

68Ga-BBN-IRDye800CW DRUG

PET/NIR fluorescent imaging-guided surgery

Also known as: IRDye800CW-BBN

68Ga-BBN-IRDye800CW PET/NIRF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Beijing Tiantan Hospital

Beijing, China

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Zhaohui Zhu, MD

  Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

  STUDY DIRECTOR

• Nan Ji, MD

  Beijing Tiantan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Chair of Brain Tumor Ward 2, associate professor

Model Details: In the first stage, a small proportion of participants receive preoperative 68Ga-IRDye800-BBN PET/CT and then

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: January 23, 2018
• Study Start: January 1, 2016
• Primary Completion: August 17, 2018
• Study Completion: August 17, 2018
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

CN (1)