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Trial Title:
68Ga-NOTA-RM26 PET/CT in Glioma Patients
NCT ID:
NCT06412952
Condition:
Glioma
Conditions: Official terms:
Glioma
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
68Ga-RM26
Description:
Intravenous injection of one dosage of 74-185 MBq(2-5 mCi) 68Ga-RM26. Tracer doses of
68Ga- RM26 will be used to image lesions of glioma by PET/CT.
Arm group label:
68Ga-RM26, PET/CT
Other name:
68Ga-GRPR antagonist
Summary:
The aim of this study was to investigate the value of 68Ga-NOTA-RM26, an antagonist
targeting gastrin-releasing peptide receptor (GRPR) PET tracer, in the diagnosis of high
WHO grade glioma and prediction the grade of glioma using positron-emission
tomography/computed tomography (PET/CT).
Detailed description:
The gastrin-releasing peptide receptor (GRPR), also known as bombesin receptor subtype II
(BB2), is a member of the G protein-coupled receptor family of bombesin receptors. GRPR
is over-expressed in various types of human tumors including breast cancer. RM26, a GRPR
antagonist with high affinity, was discovered by peptide backbone modification of
bombesin analogues.To target gastrin-releasing peptide receptor in neoplastic cells of
human breast cancer, peptide NOTA-RM26 was synthesized with a PEG3 linker between NOTA
and RM26, and then labeled with 68Ga. An open-label brain PET/ CT study was designed to
assess its clinical diagnostic value in patients with glioma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- suspected or confirmed untreated glioma patients
- signed written consent.
Exclusion Criteria:
- pregnancy
- breastfeeding
- known allergy against Pentixafor
- any medical condition that in the opinion of the investigator,may
- significantly interfere with study compliance
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese Academy of Medical Science & Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhaohui Zhu, MD
Phone:
+8619800370331
Email:
pumch_jacobwong@163.com
Start date:
October 1, 2022
Completion date:
May 31, 2024
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06412952
