A Mixed Cohort, Multicentre Exploratory Study of Non-invasive Quantitative Assessment of Renal Graft Function With Non-contrast Functional Magnetic Resonance Imaging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- Diagnostic Accuracy of Functional MRI for pathology in Kidney Transplant Recipients (Including T-Cell Mediated and Antibody-Mediated Rejection)
研究概览
简要总结
This clinical study aims to investigate a new, non-invasive method for monitoring kidney function after transplantation. Currently, assessing the health of a transplanted kidney often relies on blood tests or invasive biopsies, which may not detect subtle early changes or account for each kidney's unique starting point.
This research will use advanced, non-contrast Magnetic Resonance Imaging (MRI) scans to measure various aspects of kidney health, such as blood flow and oxygen levels. The study includes two main groups of participants: 1) kidney transplant donors and their matched recipients, and 2) transplant recipients whose donors are unavailable for study (e.g., deceased donors).
For donor-recipient pairs, the goal is to create a personalized "baseline" for each transplanted kidney by scanning the donor before donation. This allows doctors to compare the kidney's function after transplant to its own unique starting point, potentially detecting problems much earlier. For recipients without donor data, the study will evaluate how well the MRI scans can track changes in kidney function over time on their own.
Additionally, the study will analyze body composition (like fat and muscle distribution) and metabolic health to understand their relationship with transplant kidney function. We plan to enroll approximately 1000 participants across multiple hospitals. The ultimate goal is to develop a more accurate, individualized, and non-invasive tool for the early detection of transplant kidney problems, helping to improve long-term outcomes and quality of life for transplant patients.
详细描述
This is a prospective, multicenter, hybrid cohort study designed to validate a non-contrast functional MRI protocol for the non-invasive, quantitative assessment of graft function in kidney transplant recipients.
Primary Objectives:
To establish an individualized functional baseline for transplanted kidneys through donor-recipient paired studies, moving beyond population-based reference values to enable a "self-comparison" paradigm for enhanced sensitivity in detecting early graft dysfunction.
To validate the standalone capability of non-contrast functional MRI for sensitively monitoring dynamic changes in graft function in a large, independent cohort of recipients without donor baseline data (e.g., from deceased donors).
To integrate MRI parameters with body composition analysis and metabolic profiles to build a comprehensive, non-invasive assessment model for early diagnosis, treatment evaluation, and prognosis prediction of graft function.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants (age ≥ 18 years).
- •For the Paired Donor-Recipient Cohort:
- •Donor: Scheduled for living kidney donation, OR is a deceased organ donor who can undergo a pre-transplant MRI.
- •Recipient: Recipient of a kidney transplant or simultaneous pancreas-kidney transplant from the paired donor.
- •For the Independent Recipient Cohort:
- •Recipient: Recipient of a kidney transplant from a deceased donor for whom donor baseline data is unavailable.
- •Able to provide informed consent.
排除标准
- •Any contraindication to MRI (e.g., cardiac pacemaker, non-MRI compatible metallic implants, neurostimulators, severe claustrophobia).
- •Inability to tolerate the breath-holding required for MRI acquisition.
- •Any clinical condition that, in the investigator's judgment, would severely compromise study participation or data integrity (e.g., uncontrolled severe infection, active major psychiatric illness).
研究组 & 干预措施
Paired Donor-Recipient Cohort
Kidney transplant recipients enrolled along with their corresponding donor (living or deceased). The donor undergoes a pre-transplant MRI to establish an individualized functional baseline for the graft. This cohort aims to achieve ultra-sensitive detection of post-transplant functional changes by comparing against the kidney's own baseline.
Independent Recipient Cohort
Kidney transplant recipients for whom donor baseline data is unavailable (primarily recipients of deceased donor kidneys). This cohort is used to validate the standalone capability of the non-contrast MRI protocol for monitoring graft function dynamics over time, addressing the common clinical scenario where donor information is absent.
结局指标
主要结局
Diagnostic Accuracy of Functional MRI for pathology in Kidney Transplant Recipients (Including T-Cell Mediated and Antibody-Mediated Rejection)
时间窗: From the time of transplantation hospitalization until the end of the study follow-up period (up to 5 years). Assessments will be performed at each time point where a transplant kidney biopsy is deemed necessary by the clinician
At the time of each clinically indicated biopsy, the required data (e.g., for functional MRI) will be collected. The results will be compared against the reference standard of histopathological diagnosis from the concurrent transplant kidney biopsy, graded according to the updated Banff classification criteria. The primary analysis will be the diagnostic sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), each presented with a 95% confidence interval. Secondary analysis will include the correlation between the functional MRI findings and the severity grade of Banff lesions.
次要结局
- Correlation between Baseline Functional MRI Parameters and Long-Term Decline in Renal Allograft Function(From the first functional MRI assessment post-transplant, with subsequent assessments of renal function at Years 1, 2, 3, 4, and 5.)