Advanced Diffusion Imaging in Renal Cancer Patients

NYU Langone Health

Status: Enrolling

Conditions: Renal Cancer

Treatments: Device: Magnetic Resonance Imaging (MRI) Scan; Drug: Tc-99m Pentetate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06116253

21-01230

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 21 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Renal Mass Patients

Experimental group

Description:

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.

Treatment:

Drug: Tc-99m Pentetate

Device: Magnetic Resonance Imaging (MRI) Scan