Advanced Diffusion Imaging in Renal Cancer Patients

Renal Cancer Clinical Trial

Official title:

Advanced Diffusion Imaging in Renal Cancer Patients: Oncologic Control and Renal Functional Reserve

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06116253
• Other study ID #: 21-01230
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Renal Cancer

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