Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 2:21 AM
Ignite Modification Date: 2025-12-25 @ 2:21 AM
NCT ID: NCT05569434
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: NCT05569434
Study Brief:
Protocol Section: NCT05569434