FAP-targeting PET/CT for Noninvasive Monitoring of Renal Fibrosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FAP-targeting PET/CT imaging will be performed on the enrolled patients..
- Who it may be relevant to
- Registry conditions: CKD, Renal Fibrosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Chronic kidney disease (CKD) is an irreversible change of kidney function and structure caused by many reasons. The main threat of CKD to human health is progressive renal function decline. Delaying the progression of chronic kidney disease to end-stage renal failure is an important clinical need, and renal fibrosis is a common pathway for the progression of chronic kidney disease to end-stage renal failure. The evaluation of renal fibrosis is of great value for the course and prognosis of patients with chronic kidney disease. However, pathological detection has the disadvantages of trauma, false negative, and cannot be implemented repeatedly. At present, there is a lack of effective non-invasive, dynamic, real-time monitoring and evaluation means. A commercially available FAP-targeted imaging agent, FAPI-04, has been used for PET/CT imaging of systemic fibrosis lesions with high uptake background in normal kidneys. Although it can show severe renal fibrosis, it is not conducive to the detection rate of patients with mild-moderate fibrosis who need more accurate evaluation. The new targeted FAP imaging agent successfully constructed by our research group has proved that it can show the degree of renal fibrosis at the living level and has correlation. Therefore, this study intends to carry out a series of clinical studies on the imaging of renal fibrosis with new targeted FAP probes, evaluate the specificity and sensitivity of the new targeted FAP probes in the diagnosis of renal fibrosis, and ultimately provide a new method for clinical dynamic, non-invasive assessment and monitoring of the degree and progression of renal fibrosis.
Interventions
- Other FAP-targeting PET/CT imaging will be performed on the enrolled patients.
FAP-targeting PET/CT imaging will be performed on the enrolled patients.
Primary outcome measures
- Pathological type [Time frame: 1 week after enrollment]
- Baseline serum creatinine (μmol/L) [Time frame: 1 month before enrollment and 1 month after enrollment]
- Baseline 24-hour urinary protein (g/24h) [Time frame: 1 month before enrollment and 1 month after enrollment]
- Quantified renal pathological involvement. [Time frame: 1 week after enrollment]
- Pathological MESTC score [Time frame: 1 week after enrollment]
Secondary outcome measures (3)
- Follow-up serum creatinine (μmol/L) [Time frame: From 1 month after enrollment to 60 month after enrollment]
- Proteinuria remisssion [Time frame: From 1 month after enrollment to 60 month after enrollment]
- Acute kidney disease remission [Time frame: Within 3 month after enrollment]
Eligibility criteria
Inclusion criteria
- Patients with chronic kidney disease
- Renal pathology was performed within 2 weeks
Exclusion criteria
- Pregnant or lactating patients
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Peking University First Hospital — Beijing
Identifiers
NCT: NCT06563765 · 2022-386