Advanced Diffusion Imaging in Renal Cancer Patients

NCT06116253 — Not applicable, Active not recruiting, 39 participants, NYU Langone Health

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT06116253
Status	Active not recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	39 (Actual)
Sponsor	NYU Langone Health (Other); collaborators: National Institutes of Health (NIH)
Conditions	Renal Cancer
Interventions	Magnetic Resonance Imaging (MRI) Scan, Tc-99m Pentetate (Device, drug)
Dates	start 2022-12-01, primary completion 2028-12-01 (estimated), completion 2028-12-01 (estimated), first posted 2023-11-03, last updated 2026-05-08
Locations	1 site in United States

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Renal Mass Patients	Experimental	Device: Magnetic Resonance Imaging (MRI) Scan; Drug: 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.

Magnetic Resonance Imaging (MRI) Scan (Device), also known as Prisma 3T scanner: Participants will undergo a 1-hour research MRI scan.
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).

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 21 Years to 85 Years

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

+Locations (1)

Facility	City	Country	Status
NYU Langone Health	New York, New York	United States

+Study documents

Informed Consent Form (PDF, 2025-08-15)

+Investigators

Eric Sigmund, PhD, Principal investigator, NYU Langone Medical Center