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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06412952
Other study ID # PUMCH-68Ga-RM26 in Glioma
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date October 1, 2022
Est. completion date May 31, 2024

Study information

Verified date May 2024
Source Peking Union Medical College Hospital
Contact Zhaohui Zhu
Phone +8613611093752
Email 13611093752@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date May 31, 2024
Est. primary completion date May 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
68Ga-RM26
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.

Locations

Country Name City State
China Chinese Academy of Medical Science & Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary SUVmax SUVmax of focal lesions are measured on 68Ga-RM26 PET/CT. through study completion, an average of 1.5 years
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