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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)
Key laboratory of molecular imaging Chinese Academy of Sciences
Information provided by (Responsible Party):
Deling Li, Beijing Tiantan Hospital

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.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: 68Ga-BBN-IRDye800CW Device: PET/NIRF Procedure: PET/NIR fluorescent imaging-guided surgery Early Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PET-NIRF Dual Modality Imaging Guiding Surgery in Patients With Glioblastoma
Study Start Date : November 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.
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



Primary Outcome Measures :
  1. 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.

  2. Margin assessment of positive tumors in NIRF fluorescent-guided surgery [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910804


Contacts
Contact: Deling Li, MD ttyyneuroli@126.com
Contact: Jingjing Zhang, MD. zhangjingjingtag@163.com

Locations
China, Beijing
Beijing Tiantan Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Deling Li, MD.    +86 10 69154196    ttyyneuroli@126.com   
Sponsors and Collaborators
Beijing Tiantan Hospital
Peking Union Medical College Hospital
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Key laboratory of molecular imaging Chinese Academy of Sciences
Investigators
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

Responsible Party: Deling Li, Dr., Beijing Tiantan Hospital
ClinicalTrials.gov Identifier: NCT02910804     History of Changes
Other Study ID Numbers: BTHospital-N-005
ZIAEB000073 ( U.S. NIH Grant/Contract )
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018

Keywords provided by Deling Li, Beijing Tiantan Hospital:
GBM
GRPR
IRDye800
NIRF
surgery

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue