FAP-targeting PET/CT for Noninvasive Monitoring of Renal Fibrosis

Condition(s) studied

Investigational drug(s) / intervention(s)

FAP-targeting PET/CT imaging will be performed on the enrolled patients.: FAP-targeting PET/CT imaging will be performed on the enrolled patients.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Pathological type — 1 week after enrollment
  pathological type (e.g., sclerosing IgA nephropathy)
• Baseline serum creatinine (μmol/L) — 1 month before enrollment and 1 month after enrollment
  laboratory results
• Baseline 24-hour urinary protein (g/24h) — 1 month before enrollment and 1 month after enrollment
  laboratory results
• Quantified renal pathological involvement. — 1 week after enrollment
  Based on kidney biopsy sections, interstitial atrophy, interstitial inflammatory infiltration, and tubular fibrosis will be quantified.
• Pathological MESTC score — 1 week after enrollment
  MESTC score (0-2, for IgA nephropathy patients)

Trial sites (1)

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