Advanced Diffusion Imaging in Renal Cancer Patients
- Conditions
- Renal Cancer
- Interventions
- Device: Magnetic Resonance Imaging (MRI) ScanDrug: Tc-99m Pentetate
- Registration Number
- NCT06116253
- Lead Sponsor
- NYU Langone Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Renal Mass Patients Magnetic Resonance Imaging (MRI) Scan 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. Renal Mass Patients Tc-99m Pentetate 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.
- Primary Outcome Measures
Name Time Method Percentage of Times Lesion Type is Correctly Predicted using IVIM-MRI at Pre-Surgery Baseline (1 Week Prior to Operation) Intravoxel incoherent imaging-MRI (IVIM-MRI) data will be used to predict lesion type.
- Secondary Outcome Measures
Name Time Method Percentage of Times Post-Surgical Renal Function is Correctly Predicted Using REFMAP-MRI at Pre-Surgery Up to Year 1 Post-Operation Results from the Renal Flow and Microstructure AnisotroPy-MRI (REFMAP-MRI) pre-surgical scan will be considered as predictors for either stability in renal function or incremental decline in renal function following surgery that would lead to chronic kidney disease (CKD), as defined by mGFR values and proteinuria status at follow-up.
Post-surgical renal insult will be assessed based on either mGFR decline by over 2 ml/min/1.73 m2 per year or the appearance of proteinuria.
Trial Locations
- Locations (1)
NYU Langone Health
🇺🇸New York, New York, United States