Ignite Creation Date:
2024-05-06 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05728957
Status:
RECRUITING
Last Update Posted:
2023-12-14
First Post:
2023-02-06
Brief Title:
Renal Mass Biopsy PEER and 99mTc-sestamibi SPECTCT for Patients With Clinically Localized Renal Tumors
Sponsor:
Loyola University
Organization:
Loyola University
Study Overview
Official Title:
A Prospective Diagnostic Cohort Study to Compare the Accuracy of Renal Mass Biopsy PEER and 99mTc-sestamibi SPECTCT for Patients With Clinically Localized Renal Tumors
Status:
RECRUITING
Status Verified Date:
2023-12
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:
BIOPSy
Brief Summary:
The goal of this clinical trial is to better tell apart whether kidney tumors are benign not cancer or malignant cancer based on a biopsy or imaging tests and ask patients how they feel about decisions they make about treatment of their kidney tumor
The main objectives are
To estimate and compare the diagnostic accuracy of renal mass biopsy alone PEER with renal mass biopsy and 99mTc-sestamibi SPECTCT with renal mass biopsy for hot tumors to differentiate malignant and benign renal tumors
To estimate and compare the diagnostic accuracy of renal mass biopsy PEER with renal mass biopsy and 99mTc-sestamibi SPECTCT with renal mass biopsy for hot tumors to differentiate oncocytoma from chromophobe RCC
Participants will be asked to complete survey questions related to their health and kidney tumor at the start and end of the study These can be done on paper electronically or by telephone
The main objectives are
To estimate and compare the diagnostic accuracy of renal mass biopsy alone PEER with renal mass biopsy and 99mTc-sestamibi SPECTCT with renal mass biopsy for hot tumors to differentiate malignant and benign renal tumors
To estimate and compare the diagnostic accuracy of renal mass biopsy PEER with renal mass biopsy and 99mTc-sestamibi SPECTCT with renal mass biopsy for hot tumors to differentiate oncocytoma from chromophobe RCC
Participants will be asked to complete survey questions related to their health and kidney tumor at the start and end of the study These can be done on paper electronically or by telephone
Detailed Description:
The investigators are asking the participant to take part in this research study because they were diagnosed with a kidney tumor Kidney tumors can be benign not cancer or malignant cancer and the investigators hope to figure out how to better tell them apart before surgery or other treatment
The investigators hope to better tell apart whether kidney tumors are benign not cancer or malignant cancer based on a biopsy or imaging tests and ask patients how they feel about decisions they make about treatment of their kidney tumor
Biopsy is a standard test to determine if a tumor is cancerous before making a treatment decision
The imaging test 99mTc-sestamibi SPECTCT the investigators are studying has been studied before and found to help identify benign kidney tumors It is not approved by the Food and Drug Administration FDA for imaging kidney tumors It is FDA approved for use in imaging the heart and breasts It has been studied for use in parathyroid gland imaging
The participant will be asked to complete survey questions related to their health and kidney tumor at the start and end of the study The participant will receive a 99mTc-sestamibi SPECTCT scan if they have not had one already for research purposes The participant will receive a biopsy of the kidney tumor if they have not had one already as part of their routine clinical care The participant will then receive treatment of the kidney tumor as determined by consultation with their doctor
The investigators hope to better tell apart whether kidney tumors are benign not cancer or malignant cancer based on a biopsy or imaging tests and ask patients how they feel about decisions they make about treatment of their kidney tumor
Biopsy is a standard test to determine if a tumor is cancerous before making a treatment decision
The imaging test 99mTc-sestamibi SPECTCT the investigators are studying has been studied before and found to help identify benign kidney tumors It is not approved by the Food and Drug Administration FDA for imaging kidney tumors It is FDA approved for use in imaging the heart and breasts It has been studied for use in parathyroid gland imaging
The participant will be asked to complete survey questions related to their health and kidney tumor at the start and end of the study The participant will receive a 99mTc-sestamibi SPECTCT scan if they have not had one already for research purposes The participant will receive a biopsy of the kidney tumor if they have not had one already as part of their routine clinical care The participant will then receive treatment of the kidney tumor as determined by consultation with their doctor
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?:
None
Is an FDA AA801 Violation?:
None