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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06116253
Other study ID # 21-01230
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 1, 2022
Est. completion date December 1, 2026

Study information

Verified date October 2023
Source NYU Langone Health
Contact Malika Kumbella
Phone 646-501-0075
Email Malika.kumbella@nyulangone.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 1, 2026
Est. primary completion date December 1, 2026
Accepts healthy volunteers No
Gender All
Age group 21 Years to 85 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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


Related Conditions & MeSH terms


Intervention

Device:
Magnetic Resonance Imaging (MRI) Scan
Participants will undergo a 1-hour research MRI scan.
Drug:
Tc-99m Pentetate
Participants will receive radioisotope (99mTc-DTPA) injection (5 mCi) during 3-5 hour scanning session to estimate measured glomerular filtration rate (mGFR).

Locations

Country Name City State
United States NYU Langone Health New York New York

Sponsors (2)

Lead Sponsor Collaborator
NYU Langone Health National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Percentage of Times Post-Surgical Renal Function is Correctly Predicted Using REFMAP-MRI at Pre-Surgery 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.
Up to Year 1 Post-Operation
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