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

NCT ID: NCT02910804

Last Updated: 2018-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Glioblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

68Ga-BBN-IRDye800CW

Intervention Type DRUG

PET/NIRF

Intervention Type DEVICE

PET/NIR fluorescent imaging-guided surgery

Intervention Type PROCEDURE

Interventions

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68Ga-BBN-IRDye800CW

Intervention Type DRUG

PET/NIRF

Intervention Type DEVICE

PET/NIR fluorescent imaging-guided surgery

Intervention Type PROCEDURE

Other Intervention Names

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BBN-IRDye800CW Positron emission tomography/Near-infrared fluorescent

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role collaborator

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

Chinese Academy of Sciences

OTHER_GOV

Sponsor Role collaborator

Beijing Tiantan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Deling Li

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nan Ji, MD

Role: STUDY_DIRECTOR

Beijing Tiantan Hospital, Capital Medical University Beijing 100050, China

Zhaohui Zhu, MD.

Role: STUDY_DIRECTOR

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China

Locations

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Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Deling Li, MD

Role: CONTACT

Jingjing Zhang, MD.

Role: CONTACT

Facility Contacts

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Deling Li, MD.

Role: primary

+86 10 69154196

Other Identifiers

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ZIAEB000073

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BTHospital-N-005

Identifier Type: -

Identifier Source: org_study_id

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