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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03407781
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 23, 2018
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 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.

Condition or disease Intervention/treatment Phase
Glioma Drug: 68Ga-BBN-IRDye800CW Early Phase 1

Detailed Description:
Lower grade gliomas (WHO grades II and III) are currently diffused disease with variability of tumor behaviors and of challenge to distinguish the margins in white-light microscope during the surgery. An integrated dual-modality approach combining preoperative positron emission tomography imaging with intraoperative optical guidance that target the same tumor biomarker would be of grade help to solve this problem. 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 glioma. 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 imaging guiding performance in lower grade glioma patients.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: IRDye800CW-BBN PET-NIRF in Lower Grade Glioma
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : December 30, 2018
Estimated Study Completion Date : December 30, 2018

Resource links provided by the National Library of Medicine

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 or 2.0 mg/ml BBN-IRDye800CW injected intravenously for near-infrared (NIR) fluorescent imaging-guided surgery.
Drug: 68Ga-BBN-IRDye800CW
PET/NIR fluorescent imaging-guided surgery
Other Name: IRDye800CW-BBN

Primary Outcome Measures :
  1. Standardized uptake value of 68Ga-BBN-IRDye800CW in PET imaging of lower grade gliomas [ 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 lower grade glioma will be measured.

Secondary Outcome Measures :
  1. The sensitivity and specificity of intraoperative IRDye800CW-BBN fluorescence [ Time Frame: 1 year ]
    The sensitivity and specificity of intraoperative IRDye800CW-BBN fluorescence, and the preoperative PET and MRI imaging indicator for IRDye800CW-BBN fluorescence imaging in lower grade gliomas

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

Inclusion Criteria:

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

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 or PET/MRI 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 identifier (NCT number): NCT03407781

Contact: Deling Li, MD
Contact: Jingjing Zhang, MD.PhD.

Beijing Tiantan Hospital Recruiting
Beijing, China
Contact: Deling Li, MD         
Sponsors and Collaborators
Deling Li
Peking Union Medical College Hospital
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Key laboratory of molecular imaging Chinese Academy of Sciences
Study Director: 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,Capital Medical University

Responsible Party: Deling Li, Dr., Beijing Tiantan Hospital Identifier: NCT03407781     History of Changes
Other Study ID Numbers: BTHospital-N-008
ZIAEB000073 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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