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OpenTrials
Active, Not Recruiting

NCT Number: NCT06116253

Advanced Diffusion Imaging in Renal Cancer Patients

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Renal Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging (MRI) Scan

Device

Participants will undergo a 1-hour research MRI scan.

Other names: Prisma 3T scanner

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).

Primary outcomes

  1. Percentage of Times Lesion Type is Correctly Predicted using IVIM-MRI at Pre-Surgery

    Time frame: Baseline (1 Week Prior to Operation)

    Intravoxel incoherent imaging-MRI (IVIM-MRI) data will be used to predict lesion type.

Secondary outcomes

  1. Percentage of Times Post-Surgical Renal Function is Correctly Predicted Using REFMAP-MRI at Pre-Surgery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Nov 3, 2023
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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