68Ga-P16-093 PET/CT Imaging in Glioma Patients

Phase 1

Recruiting

• Conditions: Glioma
• Interventions: Drug: 68Ga-P16-093

• Registration Number: NCT05569434
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

PSMA is highly expressed on the cell surface of the microvasculature of several solid tumors, including glioma. This makes it a potentially imaging target for the detection and grading of gliomas. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with MRI in the same group of glioma patients.

Detailed Description

Glioma is the most common primary malignant brain tumor which can be divided into four grades according to different histopathological and molecular biological characteristics.Among them, glioblastoma is one of the most common types of glioma in adults (about 55%). It belongs to WHO Grade IV high-grade glioma, with a high recurrence rate, poor prognosis, and a 5-year survival rate of less than 10%. Prostate-specific membrane antigen (PSMA), as known as folate hydrolase I or glutamate carboxypeptidase II, is overexpressed on the cells of prostatic adenocarcinoma. However, PSMA is also expressed by tumor cells or neovascular endothelial cells of various solid neoplasms, such as glioma. Therefore, PSMA may be an ideal target for the diagnosis of glioma. 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, with the urea fragment of a conjugate that employs the HBED-CC chelator for labeling with 68Ga(III). The HBED-based chelating ligand binds the 68Ga3+ ion with high affinity in a pseudo-octahedral N2O4 coordination sphere by its two phenolate O, two amino-acetate carboxylate O, and two amino N donor atoms. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093 in the same group of glioma patients, compared with MRI.

Study Timeline

• Study Start: 2021-11-28
• Status Verified: 2022-10
• Study First Submitted: 2022-10-04
• Study First Submitted QC: 2022-10-04
• Last Update Submitted: 2022-10-04
• Study First Posted: 2022-10-06
• Last Update Posted: 2022-10-06
• Primary Completion: 2023-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• glioma patients highly suggested by MRI or histologically confirmed;
• 68Ga-P16-093 PET/CT and MRI within two weeks;
• signed written consent.

Exclusion Criteria

• known allergy against PSMA;
• 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-P16-093 and MRI scan	68Ga-P16-093	Within 1 week, each patient underwent MRI scan and PET/CT scan after intravenous administration of 68Ga-P16-093, respectively.

Primary Outcome Measures

Name	Time	Method
Diagnostic performance	through study completion, an average of 1 year	comparing the number of tumor detected by 68Ga-P16-093 and MRI

Secondary Outcome Measures

Name	Time	Method
standardized uptake value (SUV) of tumor	through study completion, an average of 1 year	comparing the SUVmax of tumor of different grades derived from 68Ga-P16-093

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China