68Ga-P16-093 PET/CT Imaging in Glioma Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 68Ga-P16-093 and MRI scan Within 1 week, each patient underwent MRI scan and PET/CT scan after intravenous administration of 68Ga-P16-093, respectively. |
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.
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Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
glioma patients highly suggested by MRI or histologically confirmed;
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68Ga-P16-093 PET/CT and MRI within two weeks;
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signed written consent.
Exclusion Criteria:
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known allergy against PSMA;
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any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital | Beijing | Beijing | China | 100730 |
Sponsors and Collaborators
- Peking Union Medical College Hospital
Investigators
- Principal Investigator: Zhaohui Zhu, MD, Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PekingUMCH-GBM093