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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal Mass Patients | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging (MRI) Scan | Device | Participants will undergo a 1-hour research MRI scan. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Times Lesion Type is Correctly Predicted using IVIM-MRI at Pre-Surgery | Intravoxel incoherent imaging-MRI (IVIM-MRI) data will be used to predict lesion type. | Baseline (1 Week Prior to Operation) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Times Post-Surgical Renal Function is Correctly Predicted Using REFMAP-MRI at Pre-Surgery | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Sigmund, PhD | NYU Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
This project does not contain provisions for generating public databases of anonymized individual data for future outside research. Consistent with the research plan of our funded study and the associated IRB protocol, the results of the study are made available at the aggregate level in the form of peer-reviewed publications.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 15, 2025 | May 6, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D011877 | Radionuclide Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| 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). |
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| Up to Year 1 Post-Operation |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D003947 |
| Diagnostic Techniques, Radioisotope |