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

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ClinicalTrials.gov Identifier: NCT02910804
Recruitment Status : Recruiting
First Posted : September 22, 2016
Last Update Posted : January 18, 2018
Sponsor:
Collaborators:
Peking Union Medical College Hospital
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Chinese Academy of Sciences
Information provided by (Responsible Party):
Deling Li, Beijing Tiantan Hospital

Tracking Information
First Submitted Date  ICMJE September 16, 2016
First Posted Date  ICMJE September 22, 2016
Last Update Posted Date January 18, 2018
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2016)
  • Standardized uptake value of 68Ga-BBN-IRDye800CW in PET imaging of GBM [ 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 GBM will be measured.
  • Margin assessment of positive tumors in NIRF fluorescent-guided surgery [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02910804 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IRDye800CW-BBN PET-NIRF Imaging Guiding Surgery in Patients With Glioblastoma
Official Title  ICMJE PET-NIRF Dual Modality Imaging Guiding Surgery in Patients With Glioblastoma
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 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.
Detailed Description Non-invasive preoperative PET imaging evaluation and real-time fluorescence-guided surgery would be of great help in GBM patients. 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 glioblastoma multiforme. 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 safety and imaging guiding performance of 68Ga-BBN-IRDye800CW in patients with GBM.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Glioblastoma
Intervention  ICMJE
  • Drug: 68Ga-BBN-IRDye800CW
    Other Name: BBN-IRDye800CW
  • Device: PET/NIRF
    Other Name: Positron emission tomography/Near-infrared fluorescent
  • Procedure: PET/NIR fluorescent imaging-guided surgery
Study Arms  ICMJE Experimental: 68Ga-BBN-IRDye800CW PET/NIRF
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 mg/ml BBN-IRDye800CW injected intravenously for near-infrared (NIR) fluorescent imaging-guided surgery.
Interventions:
  • Drug: 68Ga-BBN-IRDye800CW
  • Device: PET/NIRF
  • Procedure: PET/NIR fluorescent imaging-guided surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 21, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Must be able to provide a written informed consent
  • MRI imaging and/or pathological evidence of Newly Diagnosed or recurrence GBM

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 scanning
  • Pregnancy or breast feeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Deling Li, MD ttyyneuroli@126.com
Contact: Jingjing Zhang, MD. zhangjingjingtag@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02910804
Other Study ID Numbers  ICMJE BTHospital-N-005
ZIAEB000073 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Deling Li, Beijing Tiantan Hospital
Study Sponsor  ICMJE Beijing Tiantan Hospital
Collaborators  ICMJE
  • Peking Union Medical College Hospital
  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)
  • Chinese Academy of Sciences
Investigators  ICMJE
Study Director: Nan Ji, MD Beijing Tiantan Hospital, Capital Medical University Beijing 100050, China
Study Director: Zhaohui Zhu, MD. Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China
PRS Account Beijing Tiantan Hospital
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP