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

NCT03407781 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-08-06

No results posted yet for this study

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

Interventions

DRUG

68Ga-BBN-IRDye800CW

PET/NIR fluorescent imaging-guided surgery

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

    collaborator NIH

  • Chinese Academy of Sciences

    collaborator OTHER_GOV

  • Deling Li

    lead OTHER

Principal Investigators

  • Zhaohui Zhu, MD · Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

  • Nan Ji, MD · Beijing Tiantan Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-01
Primary Completion
2018-08-17
Completion
2018-08-17

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03407781 on ClinicalTrials.gov