IRDye800CW-BBN PET-NIRF Imaging Guiding Surgery in Patients With Glioblastoma

NCT02910804 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-01-18

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 glioblastoma (GBM) patients. A single dose of 40μg/111-148 Mega-Becquerel (MBq) and 1.0 mg/ml 68Ga-BBN-IRDye800CW 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

DEVICE

PET/NIRF

PROCEDURE

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
  • Beijing Tiantan Hospital

    lead OTHER

Principal Investigators

  • Nan Ji, MD · Beijing Tiantan Hospital, Capital Medical University Beijing 100050, China

  • Zhaohui Zhu, MD. · Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China

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
2015-11-30
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT02910804 on ClinicalTrials.gov