NCT02910804

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Nov 2015

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

3.1 years

First QC Date

September 16, 2016

Last Update Submit

January 16, 2018

Conditions

Glioblastoma

Keywords

GBMGRPRIRDye800NIRFsurgery

Outcome Measures

Primary Outcomes (2)

  • Standardized uptake value of 68Ga-BBN-IRDye800CW in PET imaging of GBM

    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.

    1 year

  • Margin assessment of positive tumors in NIRF fluorescent-guided surgery

    1 year

Study Arms (1)

68Ga-BBN-IRDye800CW PET/NIRF

EXPERIMENTAL

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-IRDye800CWDevice: PET/NIRFProcedure: PET/NIR fluorescent imaging-guided surgery

Interventions

68Ga-BBN-IRDye800CWDRUG
Also known as: BBN-IRDye800CW
68Ga-BBN-IRDye800CW PET/NIRF
PET/NIRFDEVICE
Also known as: Positron emission tomography/Near-infrared fluorescent
68Ga-BBN-IRDye800CW PET/NIRF
PET/NIR fluorescent imaging-guided surgeryPROCEDURE
68Ga-BBN-IRDye800CW PET/NIRF

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • 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

    STUDY DIRECTOR

Central Study Contacts

Deling Li, MD

CONTACT

ttyyneuroli@126.com

Jingjing Zhang, MD.

CONTACT

zhangjingjingtag@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 16, 2016

First Posted

September 22, 2016

Study Start

November 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

January 18, 2018

Record last verified: 2018-01

Locations

CN(1)