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

Early Phase 1

Recruiting

• Conditions: Glioma
• Interventions: Drug: 68Ga-RM26

• Registration Number: NCT06412952
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Study Timeline

• Study Start: 2022-10-01
• Study First Submitted: 2024-04-26
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-08
• Last Update Submitted: 2024-05-08
• Study First Posted: 2024-05-14
• Last Update Posted: 2024-05-14
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-RM26, PET/CT	68Ga-RM26	Inject 68Ga-Pentixafor and then perform PET/CT scan.

Primary Outcome Measures

Name	Time	Method
SUVmax	through study completion, an average of 1.5 years	SUVmax of focal lesions are measured on 68Ga-RM26 PET/CT.

Trial Locations

Locations (1)

Chinese Academy of Medical Science & Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China