Clinical trial

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

Name

PUMCH-68Ga-RM26 in Glioma

Description

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).

Trial arms

Trial start

2022-10-01

Estimated PCD

2024-05-31

Trial end

2024-05-31

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

68Ga-RM26, PET/CT

Other names:

68Ga-GRPR antagonist

Size

Primary endpoint

SUVmax

through study completion, an average of 1.5 years

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2024-05-14

1 organization

1 product

1 indication

Organization

Peking Union Medical College Hospital

Product

68Ga-RM26

Indication

Glioma