Advanced Diffusion Imaging in Renal Cancer Patients

NCT ID: NCT06116253

Last Updated: 2025-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2028-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Renal Mass Patients

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.

Group Type EXPERIMENTAL

Magnetic Resonance Imaging (MRI) Scan

Intervention Type DEVICE

Participants will undergo a 1-hour research MRI scan.

Tc-99m Pentetate

Intervention Type DRUG

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

Interventions

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Magnetic Resonance Imaging (MRI) Scan

Participants will undergo a 1-hour research MRI scan.

Intervention Type DEVICE

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).

Intervention Type DRUG

Other Intervention Names

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Prisma 3T scanner

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Sigmund, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Locations

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NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nalini Jeet

Role: CONTACT

212-263-0228

Malika Kumbella

Role: CONTACT

646-501-0075

Facility Contacts

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Malika Kumbella

Role: primary

646-501-0075

Other Identifiers

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21-01230

Identifier Type: -

Identifier Source: org_study_id

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