Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428708
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-05-20
Brief Title:
18F PSMA-1007 PETCT in Metastatic Clear Cell Renal Cell Carcinoma
Sponsor:
Western University
Organization:
Western University
Study Overview
Official Title:
Comparison of 18F PSMA-1007 PETCT and Conventional Imaging in the Detection of Metastatic Clear Cell Renal Cell Carcinoma
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 10105 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None