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

NCT05728957 | Recruiting DMC

• 1 other identifier: 215278
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Kidney Tumor; Renal Benign Neoplasm; Renal Malignant Tumor

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Histologic Classification (malignant vs. benign)

  The classification of each tumor as malignant or benign by the diagnostic approaches of interest will be compared to the primary endpoint of malignant vs. benign based on surgical pathology or biopsy.

  Until surgical extirpation or 1 year repeat biopsy

Secondary Outcomes (3)

• Histologic Classification (RCC vs. oncocytoma)

  30 days after surgical extirpation or 1 year repeat biopsy

• Non-diagnostic rate for renal mass biopsy

  30 days after surgical extirpation or 1 year repeat biopsy

• Patient-reported measures/outcomes related to mental health, physical health, distress, and regret

  30 days after surgical extirpation or 1 year repeat biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be 18 years of age and older, male or female and diagnosed with a kidney tumor. Kidney tumors can be benign (not cancer) or malignant (cancer).

You may qualify if:

• Participants diagnosed with a clinically localized (cT1) renal tumor ≤7cm in size with a solid component suspicious for malignancy based on cross-sectional imaging
• 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
• Participants must be greater than or equal to 18 years of age
• Eligible or planned to undergo partial or radical nephrectomy as determined by primary urologist
• Eligible or planned to receive renal mass biopsy as determined by primary urologist
• Estimated glomerular filtration rate of ≥30 ml/min/1.73 m2 as calculated by the CKD-EPI (Chronic Kidney Disease-Epidemiology Collaboration) Equation

You may not qualify if:

• Participants must not be pregnant (as determined by local policy by radiology / imaging center)
• Participants must not have evidence of clinical nodal or distant metastasis.
• Participants must not have had a history of other malignancy with concern for renal metastasis.
• Participants must not have any known allergy to technetium or sestamibi.

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, Urine, and/or Tissue

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Hiten D Patel, MD, MPH

  Loyola University

  PRINCIPAL INVESTIGATOR

• Gopal N Gupta, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gopal N Gupta, MD

CONTACT

708-216-8467; gogupta@lumc.edu

Agnes Natonton

CONTACT

708-327-3295; anatont@luc.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliate Assistant Professor

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: February 15, 2023
• Study Start: February 1, 2023
• Primary Completion (Estimated): February 1, 2033
• Study Completion (Estimated): December 1, 2033
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)