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

Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05569434
• Other study ID #: PekingUMCH-GBM093
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 28, 2021
• Est. completion date: December 2024

Study information

• Verified date: October 2022
• Source: Peking Union Medical College Hospital
• Contact: Zhaohui Zhu, MD
• Phone: 86-13611093752
• Email: 13611093752[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioma

Intervention

Drug:
• 68Ga-P16-093
Intravenous injection of 68Ga-P16-093 with the dosage of 1.5-1.8 MBq (0.04-0.05 mCi)/kg. Tracer doses of 68Ga-P16-093 will be used to image lesions of glioma by PET/CT.

Locations

Country	Name	City	State
China	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	Diagnostic performance	comparing the number of tumor detected by 68Ga-P16-093 and MRI	through study completion, an average of 1 year
Secondary	standardized uptake value (SUV) of tumor	comparing the SUVmax of tumor of different grades derived from 68Ga-P16-093	through study completion, an average of 1 year