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临床试验/NCT06116253
NCT06116253
招募中
不适用

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

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 90 人2022年12月1日

概览

阶段
不适用
干预措施
Magnetic Resonance Imaging (MRI) Scan
疾病 / 适应症
Renal Cancer
发起方
NYU Langone Health
入组人数
90
试验地点
1
主要终点
Percentage of Times Lesion Type is Correctly Predicted using IVIM-MRI at Pre-Surgery
状态
招募中
最后更新
10个月前

概览

简要总结

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.

注册库
clinicaltrials.gov
开始日期
2022年12月1日
结束日期
2028年12月1日
最后更新
10个月前
研究类型
Interventional
研究设计
Single Group
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Renal mass patients scheduled for laparoscopic partial nephrectomy.
  • eGFR above 30 ml/min/m
  • Ages 21 to 85
  • Must be willing and able to provide consent.

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Magnetic Resonance Imaging (MRI) Scan

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.

干预措施: Tc-99m Pentetate

结局指标

主要结局

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

时间窗: Baseline (1 Week Prior to Operation)

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

次要结局

  • Percentage of Times Post-Surgical Renal Function is Correctly Predicted Using REFMAP-MRI at Pre-Surgery(Up to Year 1 Post-Operation)

研究点 (1)

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