Clinical trial NCT03407781: IRDye800CW-BBN PET-NIRF Imaging Guiding Surgery in Patients With Lower Grade Glioma
Official title: IRDye800CW-BBN PET-NIRF in Lower Grade Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glioma
Keywords: fluorescence guided surgery; dual-modality imaging
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: 2018-01-23
Enrollment: 52
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
Intervention model description: In the first stage, a small proportion of participants receive preoperative 68Ga-IRDye800-BBN PET/CT and then
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 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.

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/ NIRF study was designed to investigate the imaging guiding performance in lower grade glioma patients. To investigate whether the preoperative PET with BBN can predict the success of the fluorescence guided surgery with same peptide intraoperatively. The sensitivity, specificity and accuracy of fluorescence guided sampling intraoperatively according to the final pathology will be assessed as well.

Eligibility criteria: 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

Primary outcomes:
measure: Standardized uptake value of 68Ga-BBN-IRDye800CW in PET imaging of lower grade gliomas
timeFrame: 1 year
Secondary outcomes:
measure: The sensitivity and specificity of intraoperative IRDye800CW-BBN fluorescence
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
Study officials:
affiliation: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
name: Zhaohui Zhu, MD
role: STUDY_DIRECTOR
affiliation: Beijing Tiantan Hospital
name: Nan Ji, MD
role: STUDY_DIRECTOR
References: