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

Glioblastoma Clinical Trial

Official title:

PET-NIRF Dual Modality Imaging Guiding Surgery in Patients With Glioblastoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02910804
• Other study ID #: BTHospital-N-005
• Secondary ID: ZIAEB000073
• Status: Recruiting
• Phase: Early Phase 1
• First received: September 16, 2016
• Last updated: January 16, 2018
• Start date: November 2015
• Est. completion date: December 2018

Study information

• Verified date: January 2018
• Source: Beijing Tiantan Hospital
• Contact: Deling Li, MD
• Email: ttyyneuroli[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 µ?)

• 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

Related Conditions & MeSH terms

• Glioblastoma

Intervention

Drug:
• 68Ga-BBN-IRDye800CW

Device:
• PET/NIRF

Procedure:
• PET/NIR fluorescent imaging-guided surgery

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Key laboratory of molecular imaging Chinese Academy of Sciences, National Institute for Biomedical Imaging and Bioengineering (NIBIB), Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Margin assessment of positive tumors in NIRF fluorescent-guided surgery		1 year