Skip to content

68Ga-P16-093 and 18F-FDG PET/CT Imaging in the Same Group of Clear Cell Renal Cell Carcinoma Patients

A Pilot Comparison of 68Ga-P16-093 and 18F-FDG PET/CT Imaging in the Same Group of Clear Cell Renal Cell Carcinoma Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05432947
Enrollment
42
Registered
2022-06-27
Start date
2022-04-14
Completion date
2022-09-15
Last updated
2022-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clear Cell Renal Cell Carcinoma

Brief summary

PSMA is highly expressed on the cell surface of the microvasculature of several solid tumors, including clear cell renal cell carcinoma (ccRCC). This makes it a potentially imaging target for the detection of ccRCC. This pilot study was designed to evaluate the diagnostic performance of 68Ga-P16-093, a novel radiopharmaceutical targeting PSMA, which was compared with 18F-FDG PET/CT in the same group of ccRCC patients.

Detailed description

Renal cell carcinoma (RCC) is the most common solid tumor within the kidney and accounts for approximately 3% of all malignancies in the world. Clear cell RCC (ccRCC) is the most common subtype and accounts for the majority of kidney cancer-related deaths. Importantly, pro-angiogenic factors (VEGF, PDGF) are strongly upregulated in clear cell RCC, leading to high vascularized tumors. 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 renal cell carcinoma. Therefore, PSMA may be an ideal target for the diagnosis of ccRCC. 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 ccRCC patients, compared with 18F-FDG PET/CT.

Interventions

Intravenous injection of 68Ga-P16-093 with a dosage of 1.8-2.2 MBq (0.05-0.06 mCi)/kg.

DRUG18F-FDG

Intravenous injection of 18F-FDG with a dosage of 5.55 MBq (0.15 mCi)/kg.

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* patients with confirmed or suspected clear cell Renal cell carcinoma; * 68Ga-P16-093 18F-FDG PET/CT within a week; * signed written consent.

Exclusion criteria

* pregnancy; * breastfeeding; * known allergy against PSMA; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic performancethrough study completion, an average of 1 yearcomparing the number of tumor detected by 68Ga-P16-093 and 18F-FDG PET/CT

Secondary

MeasureTime frameDescription
standardized uptake value (SUV) of tumorthrough study completion, an average of 1 yearcomparing the SUVmax of tumor derived from 68Ga-P16-093 and 18F-FDG PET/CT

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026