NCT06428708

[18F] PSMA-1007 PET/CT in Metastatic Clear Cell Renal Cell Carcinoma

Comparison of [18F] PSMA-1007 PET/CT and Conventional Imaging in the Detection of Metastatic Clear Cell Renal Cell Carcinoma

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Western University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Staging of kidney cancer is primarily achieved by computerized tomography (CT) scans or magnetic resonance imaging (MRI). If a patient is found to have limited metastatic disease, surgical removal or radiation therapy could be considered in order to control the majority of the disease. However, if metastases are more widespread, systemic (drug) therapy may be the preferred management option. The identification of additional metastatic sites using more sensitive imaging modalities therefore has the potential to alter management, and this remains an unmet need in the field. This study will investigate the utility of positron emission tomography (PET) imaging with PSMA (prostate specific membrane antigen). Kidney cancer of the clear cell subtype has demonstrated high expression of PSMA, making it a disease in which PSMA-targeted PET imaging could help to identify occult metastatic disease.

Detailed description

This will be a single-institution prospective, open-label feasibility study involving patients ≥18 years of age with metastatic clear cell RCC who have not yet received systemic therapy. Patients with evidence of metastatic disease on conventional imaging will require histologic confirmation by biopsy. At our institution, approximately 26 new metastatic clear cell RCC (mRCC) patients are seen each year, and a previous analysis reported that 92% of 10,105 patients with mRCC in the International mRCC Database Consortium (IMDC) database were found to have clear cell histology; therefore, difficulty with recruitment into this study over a period of 2 years is not anticipated.

Conditions

• Metastatic Clear Cell Renal Cell Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	[18F] PSMA-1007 PET/CT	\[18F\] PSMA-1007 PET/CT scan

Timeline

• Start date: 2022-01-24
• Primary completion: 2024-12-01
• Completion: 2025-09-01
• First posted: 2024-05-24
• Last updated: 2024-06-25

Locations

1 site across 1 country: Canada