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

January 16, 2018 updated by: Deling Li

IRDye800CW-BBN PET-NIRF in Lower Grade Glioma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

30

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Tiantan hospital
        • Contact:
          • Deling Li, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • IRDye800CW-BBN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deling Li

Collaborators

Peking Union Medical College Hospital
Chinese Academy of Sciences
National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2016

Primary Completion (ANTICIPATED)

December 30, 2018

Study Completion (ANTICIPATED)

December 30, 2018

Study Registration Dates

First Submitted

January 16, 2018

First Submitted That Met QC Criteria

January 16, 2018

First Posted (ACTUAL)

January 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTHospital-N-008
  • ZIAEB000073 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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