68Ga-NOTA-RM26 PET/CT in Glioma Patients

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Early Phase 1

Conditions: Glioma

Treatments: Drug: 68Ga-RM26

Study type: Interventional

Funder types: Other

Identifiers

NCT06412952

PUMCH-68Ga-RM26 in Glioma

Details and patient eligibility

About

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).

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

68Ga-RM26, PET/CT

Experimental group

Description:

Inject 68Ga-Pentixafor and then perform PET/CT scan.

Treatment:

Drug: 68Ga-RM26