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Trial Title:
Advanced Diffusion Imaging in Renal Cancer Patients
NCT ID:
NCT06116253
Condition:
Renal Cancer
Conditions: Official terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Pentetic Acid
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Magnetic Resonance Imaging (MRI) Scan
Description:
Participants will undergo a 1-hour research MRI scan.
Arm group label:
Renal Mass Patients
Other name:
Prisma 3T scanner
Intervention type:
Drug
Intervention name:
Tc-99m Pentetate
Description:
Participants will receive radioisotope (99mTc-DTPA) injection (5 mCi) during 3-5 hour
scanning session to estimate measured glomerular filtration rate (mGFR).
Arm group label:
Renal Mass Patients
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
21 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
NYU Langone Health
Address:
City:
New York
Zip:
10016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Malika Kumbella
Phone:
646-501-0075
Email:
Malika.kumbella@nyulangone.org
Start date:
December 1, 2022
Completion date:
December 1, 2028
Lead sponsor:
Agency:
NYU Langone Health
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Source:
NYU Langone Health
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06116253
