Clinical trial NCT02910804: IRDye800CW-BBN PET-NIRF Imaging Guiding Surgery in Patients With Glioblastoma
Official title: PET-NIRF Dual Modality Imaging Guiding Surgery in Patients With Glioblastoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Glioblastoma
Keywords: GBM
GRPR
IRDye800
NIRF
surgery
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
name: Chinese Academy of Sciences
First posted: 2016-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Standardized uptake value of 68Ga-BBN-IRDye800CW in PET imaging of GBM
timeFrame: 1 year
measure: Margin assessment of positive tumors in NIRF fluorescent-guided surgery
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital, Capital Medical University Beijing 100050, China
name: Nan Ji, MD
role: STUDY_DIRECTOR
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, China
name: Zhaohui Zhu, MD.
role: STUDY_DIRECTOR
References: