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

NCT ID: NCT05432947

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-14
• Study Completion Date: 2022-09-15

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.

Conditions

Clear Cell Renal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

68Ga-P16-093 and 18F-FDG PET/ CT scan

Within 1 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-P16-093 and 18F-FDG, respectively.

Group Type: EXPERIMENTAL

68Ga-P16-093

Intervention Type: DRUG

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

18F-FDG

Intervention Type: DRUG

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

Interventions

68Ga-P16-093

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

Intervention Type: DRUG

18F-FDG

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

Intervention Type: DRUG

Other Intervention Names

68Ga-P16-093 injection; 18F-FDG injection

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhaohui Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

References

Wang G, Li L, Wang J, Zang J, Chen J, Xiao Y, Fan X, Zhu L, Kung HF, Zhu Z. Head-to-head comparison of [68Ga]Ga-P16-093 and 2-[18F]FDG PET/CT in patients with clear cell renal cell carcinoma: a pilot study. Eur J Nucl Med Mol Imaging. 2023 Apr;50(5):1499-1509. doi: 10.1007/s00259-022-06101-3. Epub 2023 Jan 5.

Reference Type: DERIVED

PMID: 36600099 (View on PubMed)

Other Identifiers

PUMCH NM-RCC

Identifier Type: -

Identifier Source: org_study_id