RECRUITING

Renal Mass Biopsy, PEER, and 99mTc-sestamibi SPECT/CT for Patients With Clinically Localized Renal Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 SPECT/CT (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 SPECT/CT (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.

Official Title

A Prospective Diagnostic Cohort Study to Compare the Accuracy of Renal Mass Biopsy, PEER, and 99mTc-sestamibi SPECT/CT for Patients With Clinically Localized Renal Tumors

Quick Facts

Study Start:2023-02-01
Study Completion:2033-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05728957

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants diagnosed with a clinically localized (cT1) renal tumor ≤7cm in size with a solid component suspicious for malignancy based on cross-sectional imaging
  2. * Pre-existing CT images of the mass with and without contrast or planned CT to ensure both with and without contrast images of the mass have been obtained within a 365-day window
  3. * Participants must be greater than or equal to 18 years of age
  4. * Eligible or planned to undergo partial or radical nephrectomy as determined by primary urologist
  5. * Eligible or planned to receive renal mass biopsy as determined by primary urologist
  6. * Estimated glomerular filtration rate of ≥30 ml/min/1.73 m2 as calculated by the CKD-EPI (Chronic Kidney Disease-Epidemiology Collaboration) Equation
  1. * Participants must not be pregnant (as determined by local policy by radiology / imaging center)
  2. * Participants must not have evidence of clinical nodal or distant metastasis.
  3. * Participants must not have had a history of other malignancy with concern for renal metastasis.
  4. * Participants must not have any known allergy to technetium or sestamibi.

Contacts and Locations

Study Contact

Gopal N Gupta, MD
CONTACT
708-216-8467
gogupta@lumc.edu
Agnes Natonton
CONTACT
708-327-3295
anatont@luc.edu

Principal Investigator

Hiten D Patel, MD, MPH
PRINCIPAL_INVESTIGATOR
Loyola University
Gopal N Gupta, MD
PRINCIPAL_INVESTIGATOR
Loyola University

Study Locations (Sites)

Loyola University Medical Center
Maywood, Illinois, 60153
United States

Collaborators and Investigators

Sponsor: Loyola University

  • Hiten D Patel, MD, MPH, PRINCIPAL_INVESTIGATOR, Loyola University
  • Gopal N Gupta, MD, PRINCIPAL_INVESTIGATOR, Loyola University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-01
Study Completion Date2033-12

Study Record Updates

Study Start Date2023-02-01
Study Completion Date2033-12

Terms related to this study

Keywords Provided by Researchers

  • Kidney Tumor
  • Survey Questions
  • Benign
  • Malignant
  • Renal Benign Neoplasm
  • Renal Malignant Tumor
  • Nuclear Imaging
  • Computed Tomography

Additional Relevant MeSH Terms

  • Kidney Tumor
  • Renal Benign Neoplasm
  • Renal Malignant Tumor