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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前:Constantin N Aschauer, MD
- 電話番号:004314040043910
- メール:constantin.aschauer@muv.ac.at
研究連絡先のバックアップ
- 名前:Rainer Oberbauer, MD, PhD, MD, PhD
- 電話番号:004314040043900
- メール:rainer.oberbauer@meduniwien.ac.at
研究場所
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State of Vienna
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Vienna、State of Vienna、オーストリア、1090
- 募集
- General hospital Vienna
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コンタクト:
- Constantin N Aschauer, MD
- 電話番号:004314040043910
- メール:constantin.aschauer@muv.ac.at
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参加基準
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Histological workup of native kidney present
Exclusion Criteria:
- Age <18
- Pregnancy
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:診断
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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他の: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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この研究は何を測定していますか?
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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.
時間枠: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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協力者と研究者
捜査官
捜査官
- 主任研究者:Rainer Oberbauer, MD, PhD、Medical University of Vienna, Internal Medicine III, Department of Nephrology and Dialysis
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 1363/2025
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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