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

Last updated: October 4, 2022
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

1/2

Condition

Brain Tumor

Cancer/tumors

Neurofibromatosis

Treatment

N/A

Clinical Study ID

NCT05569434
PekingUMCH-GBM093
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • known allergy against PSMA;
  • any medical condition that in the opinion of the investigator may significantlyinterfere with study compliance.

Study Design

Total Participants: 50
Study Start date:
November 28, 2021
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.