研究の詳細
開始日： 2022 年 8 月 16 日
完了予定： September 2024
最終更新： 2023 年 8 月 14 日
開発の段階：
フェーズ1
サイズ/登録： 12
研究の説明： The goal of this project is to perform a proof-of-concept study to compare the ability of quantitative parametric cardiac 18F-flutemetamol positron emission tomography (PET) to assess baseline and change in disease burden after six months of therapy with tafamidis treatment in 12 patients diagnosed with transthyretin cardiac amyloidosis (ATTR-CA) at Yale-New Haven Hospital. The primary outcome of the study will be comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET metrics between the baseline and six-month 18F-flutemetamol PET scans versus clinical stage and echocardiographic features (wall thickness, strain, LVEF).
主な結果：
- Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET visual uptake scores between the baseline and six-month PET scans
- 6か月間
Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET percent maximal counts between the baseline and six-month PET scans
- 6か月間
Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET Standardized Uptake Values (SUVs) between the baseline and six-month PET scans
- 6か月間
Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET retention index between the baseline and six-month PET scans
- 6か月間
Determine if ATTR cardiomyopathy disease severity is associated with increased 18F-flutemetamol
As determined by comparisons in the magnitude of change in regional and global 18F-flutemetamol cardiac PET Vt between the baseline and six-month PET scans
- 6か月間
Determine if treatment with tafamidis reduces 18F-flutemetamol cardiac PET imaging markers
As assessed by dynamic cardiac PET between baseline and 6 months
- 6か月間
二次的結果：
- Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
6か月間
- Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
6か月間
- Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
6か月間
- Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
6か月間
- Compare changes in 18F-flutemetamol PET variables and measures of ATTR clinical response
6か月間
選択基準：
• 対象年齢: 18 歳以上
•適格な性別：すべて
包含基準：
1. Age > 18 years
2. Diagnosis of ATTR cardiac amyloidosis (wild-type or V142I ATTR mutation)
a. Diagnosis of ATTR cardiac amyloidosis by established consensus diagnostic criteria of Gillmore et al. (either invasive or non-invasive diagnostic pathways)
3. Plan for initiation of tafamidis therapy for clinical indications and agree to continue tafamidis during the duration of the study.
4. Stated willingness to comply with all study procedures and availability for the duration of the study
5. Able to understand and sign the informed consent document after the nature of the study has been fully explained.
6. Women of childbearing potential who are sexually active with a non-sterilized male partner and males who are sexually active with a partner of childbearing potential must agree to use adequate contraception from screening until 30 days after the Flutemetamol.
除外基準： 基準：
1. Primary amyloidosis (AL) or secondary amyloidosis (AA).
2. Prior liver or heart transplantation.
3. Active malignancy or non-amyloid disease with an expected survival of less than 1 year
4. Inability to lie flat for 60 minutes in the PET scanner
5. History of prior treatment for ATTR cardiomyopathy and/or amyloid neuropathy, or decline clinical tafamidis treatment.
6. Pregnancy or lactation
7. Known allergic reactions to components of the 18F-flutemetamol and/or polysorbate 80
8. High risk for non-adherence as determined by screening evaluation.
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