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

StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later May 10, 2026 → May 10, 2027
See other at-risk trials from Peking University First Hospital

Record History

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  1. Notable Primary completion pushed from May 10, 2026 to May 10, 2027 Show 4 more changesShow less
    • Primary endpoints: details revised at 2 of 5 entries
    • Interventions: FAP-targeting PET/CT imaging will be performed on the enrolled patients. (Other) to FAP-targeting PET/CT imaging will be performed on the enrolled patients. (Other)
    • Secondary endpoints: details revised at 3 of 3 entries
    • Eligibility criteria expanded, about 3 words
  2. Notable Enrollment target: 90 to 150
    • Primary endpoints: 4 to 5
    • Secondary endpoints expanded, about 10 words
    v3
  3. Notable Primary completion date: May 10, 2025 to May 10, 2026
    • Study completion date: May 10, 2026 to May 10, 2027
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06563765
Lead Sponsor Peking University First Hospital
Conditions
(from sponsor)
CKD, Renal Fibrosis
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov