Evaluation of Kidney Fibrosis Via FAPI PET/CT
Evaluation of Renal Renal Fibrosis Vie FAPI-PET-CT: a Prospective Non-randomized Open-label Single-center Pilot Study
Interstitial fibrosis is a hallmark of progression in chronic kidney disease (CKD), yet it can presently be assessed only by kidney biopsy, which is invasive and prone to sampling error.
In recent years the advances in molecular imaging, especially high spatial and temporal resolution of the scanners and the development of radiopharmaceuticals to visualize metabolic processes or immune cells have been significant, opening promising possibilities in multiple fields. It was demonstrated that in autoimmune diseases as Crohns disease the use of fibrosis markers, as 68Ga-FAPI tracer in PET/MRI could adequately reflect the amount of fibrosis found in histologic work up of tissue specimens in the gut. Also first data in small studies including patients with chronic kidney disease showed promising results indicating that tracer uptake could reflect the degree of fibrosis.
This study aims to investigate the utility of PET/CT imaging with a [68Ga]-DOTA.SA.FAPi tracer to reflect the degree of fibrosis found in the histological work up. We hypothesize that PET/CT findings reflect histological found fibrotic changes in kidney biopsies, potentially offering a superior alternative due to its non-invasive nature and the possibility to capture the entire organ.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Background More than 10% of the general population worldwide is affected by chronic kidney disease (CKD) and approximately four million people are living on renal replacement therapy. Main causes for CKD are life style factors as hypertension and diabetes. Modern therapies improve outcome and reduce disease progression and can sustain organ function by reducing fibrosis as disease progression is mostly characterized by progressive tissue remodeling, especially including fibrosis leading to GFR reduction. To quantify the degree of fibrosis an invasive procedure as the kidney biopsy is necessary.The procedure and preparation for native kidney and graft biopsies requires detailed planning as bleeding risk and consecutive consequences of bleeding potentially leading to nephrectomy have to be minimized. Nevertheless, significant complications as erythrocyte transfusions are observed in up to 1,6 % and in 0,3% invasive interventions are needed to stop bleeding following kidney biopsies. These complications occur despite optimal preparation and in significant cases a biopsy is not feasible due to vital platelet inhibition and anticoagulation or these have to be paused for several days prior to biopsy reflecting a significant time loss.
Additionally in patients with a long known CKD and comorbidities (exg. hypertension, hyperglycemia) where a rapid decrease in kidney function also with concomitant significant proteinuria can reflect the natural slope of kidney function decline and histologic biopsy work up eventually often reveals chronic lesions and extended fibrosis as cause for progressive decline in kidney function.
In these cases and due to the mentioned difficulties and significant periprocedural risk, a non-invasive tool to bona fide visualize ongoing processes or existing damage in the kidney is preferable and due to advances in imaging techniques a promising approach.
PET Imaging In recent years the advances in molecular imaging, especially high spatial and temporal resolution of the scanners and the development of radiopharmaceuticals to visualize metabolic processes or immune cells have been significant, opening promising possibilities in multiple fields.
Nowadays widely used FDG PET/CT has proven its use in clinical practice in detecting areas of high metabolism as inflammation or cancer. By the use of alternative radiopharmaceuticals, further processes like blood flow, cell proliferation or receptor distribution in organs can be quantified at the molecular level. Fibrosis evaluation using 68Ga-FAPI tracer demonstrated that in autoimmune diseases as Crohns disease the use of fibrosis markers in PET/MRI could adequately reflect the amount of fibrosis found in histologic work up of tissue specimens in the gut and small studies have already shown promising results in fibrosis evaluation in native kidneys.
Methods We aim to prospectively include 30 patients with different degrees of fibrosis in the kidney biopsy and perform a PET/CT scan using 68Ga-DOTA.SA.FAPi tracer to evaluate a correlation between tracer uptake and the histologic findings.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Constantin N Aschauer, MD
- 전화번호: 004314040043910
- 이메일: constantin.aschauer@muv.ac.at
연구 연락처 백업
- 이름: Rainer Oberbauer, MD, PhD, MD, PhD
- 전화번호: 004314040043900
- 이메일: rainer.oberbauer@meduniwien.ac.at
연구 장소
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State of Vienna
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Vienna, State of Vienna, 오스트리아, 1090
- 모병
- General hospital Vienna
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연락하다:
- Constantin N Aschauer, MD
- 전화번호: 004314040043910
- 이메일: constantin.aschauer@muv.ac.at
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-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Histological workup of native kidney present
Exclusion Criteria:
- Age <18
- Pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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다른: FAPI PET/CT scan
All included patients will have a FAPI PET/CT scan
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Included patients will undergo one PET/CT scan with 68GA-FAPI tracer application
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Correlation of SUVmax and SUVmean with degree of fibrosis in the kidney biopsy assessed by H-score, firbotic area and intensitiy grade.
기간: Patients are included on behalf of the kidney biopsy result and one PET/CT scan will be performed. The statistical analysis and interpretation will be performed immediately after the PET/CT scan.
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The Spearman rank correlation coefficient will be used to quantify the associations between the renal PET parameters (SUVmean, SUVmax and SUVpeak) and the histological measures of fibrosis (H-score, fibrotic area and intensity grade).
Firbotic area: the percentage of any fibrotic area of the cortical part of the entire biopsy core by visual assessment (in 10% increments); fibrotic grade: an ordinal interstitial fibrosis intensity grade by visual assessment of distension of tubules and staining intensity (0 = ab-sent/nearly absent, I = mild, II = moderate, III = severe) - the most abundant grade was chosen.H-score (0-300) derived from fibrotic area percentages and corre-sponding severity grades (0-3).
Statistics will be performed with Rstudio.
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Patients are included on behalf of the kidney biopsy result and one PET/CT scan will be performed. The statistical analysis and interpretation will be performed immediately after the PET/CT scan.
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Rainer Oberbauer, MD, PhD, Medical University of Vienna, Internal Medicine III, Department of Nephrology and Dialysis
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 비뇨생식기 질환
- 병리학적 과정
- 남성 비뇨 생식기 질환
- 신장 질환
- 비뇨기과 질환
- 여성 비뇨 생식기 질환
- 여성 비뇨 생식기 질환 및 임신 합병증
- 만성 질환
- 질병 속성
- 신부전
- 병리학적 상태, 징후 및 증상
- 섬유증
- 신부전, 만성
- 진단 기술 및 절차
- 진단
- 단층 촬영
- 진단 이미징
- 방사선 촬영
- 이미지 해석, 컴퓨터 보조
- 방사선 이미지 향상
- 이미지 향상
- 사진술
- 단층 촬영, X- 레이
- 단층 촬영, 방출량
- 방사성 핵종 영상
- 진단 기술, 방사성 동위 원소
- 양전자 방출 단층 촬영
- 단층 촬영, X- 레이 계산
- 멀티 모달 이미징
- 양전자 방출 단층 촬영 컴퓨터 단층 촬영
기타 연구 ID 번호
기타 연구 ID 번호
- 1363/2025
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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