Advanced Diffusion Imaging in Renal Cancer Patients

NCT06116253 | Active Not Recruiting DMC

• 1 other identifier: 21-01230
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to apply advanced diffusion imaging in a two-pronged assessment of renal mass patients: (1) characterization of lesion malignancy and subtype, and (2) prediction of renal function stability or decline following partial nephrectomy.

Conditions

Renal Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of Times Lesion Type is Correctly Predicted using IVIM-MRI at Pre-Surgery

  Intravoxel incoherent imaging-MRI (IVIM-MRI) data will be used to predict lesion type.

  Baseline (1 Week Prior to Operation)

Secondary Outcomes (1)

• Percentage of Times Post-Surgical Renal Function is Correctly Predicted Using REFMAP-MRI at Pre-Surgery

  Up to Year 1 Post-Operation

Study Arms (1)

Renal Mass Patients

EXPERIMENTAL

Patients will be enrolled for 2 MRI visits. These visits will include an approximately 1 hour research MRI scan and a total of between 3 and 5 hours Tc-99m DTPA scan. In each MRI visit, patients will be scanned for approximately one hour including both standard-of-care clinical sequences and research-based Advanced Diffusion Imaging sequences, on a Prisma 3T MRI scanner. Following the MRI exam or on a day not more than a week after the MRI exam, patients will undergo renal function assessment via Tc-99m DTPA scan and patient's kidneys will be scanned using a gamma camera. Proteinuria will be assessed by standard of care urinalysis of specimens collected at each MRI visit for each patient. Blood test will be performed at each visit to estimate GFR (eGFR) from measurement of serum creatinine.

Device: Magnetic Resonance Imaging (MRI) Scan; Drug: Tc-99m Pentetate

Interventions

Magnetic Resonance Imaging (MRI) Scan DEVICE

Participants will undergo a 1-hour research MRI scan.

Also known as: Prisma 3T scanner

Renal Mass Patients

Tc-99m Pentetate DRUG

Participants will receive radioisotope (99mTc-DTPA) injection (5 mCi) during 3-5 hour scanning session to estimate measured glomerular filtration rate (mGFR).

Renal Mass Patients

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Renal mass patients scheduled for laparoscopic partial nephrectomy.
• eGFR above 30 ml/min/m2.
• Ages 21 to 85
• Must be willing and able to provide consent.

You may not qualify if:

• All metal implants and dental implants that have ferromagnetic properties and are unsafe at 3.0 T.
• Pregnant women are not eligible for participating in this study.
• Acute claustrophobia

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms

Interventions

Magnetic Resonance Imaging; Radionuclide Imaging

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Radioisotope

Study Officials

• Eric Sigmund, PhD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 3, 2023
• Study Start: December 1, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)