Advanced Diffusion Imaging in Renal Cancer Patients

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06116253

Enrollment

Registered

2023-11-03

Start date

2022-12-01

Completion date

2028-12-01

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cancer

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.

Interventions

DEVICEMagnetic Resonance Imaging (MRI) Scan

Participants will undergo a 1-hour research MRI scan.

DRUGTc-99m Pentetate

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Contacts

Primary ContactNalini Jeet

Nalini.jeet@nyulangone.org212-263-0228

Backup ContactMalika Kumbella

Malika.kumbella@nyulangone.org646-501-0075

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026