2022-500186-27-00招募中3 期
An open-label, multi-center, non-randomized pivotal Phase 3 study to evaluate the efficacy and safety of [18F]florbetaben Positron Emission Tomography (PET) imaging to diagnose cardiac AL amyloidosis
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 169
- 试验地点
- 11
- 主要终点
- The co-primary efficacy variables will be the sensitivity and specificity of the visual assessment of [18F]florbetaben PET images for the diagnosis of cardiac AL amyloidosis
研究概览
简要总结
To determine the sensitivity and specificity of the visual assessment of [18F]florbetaben PET images for the diagnosis of cardiac AL amyloidosis by using the standard of care clinical diagnosis
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Males and females age ≥18 years
- •Able to understand, sign and date written informed consent
- •Written informed consent must be obtained before any assessment is performed
- •Subjects being considered for a possible diagnosis of cardiac amyloidosis by:
- •One of the following conditions: - Established systemic amyloidosis without proven cardiac involvement, - Known plasma cell dyscrasia (MGUS, multiple myeloma), - Pathological free light chain levels in urine or serum, - Presence of heart failure with preserved ejection fraction;
- •AND one of the following parameters, indicative of cardiac manifestation: - Mean (left ventricular (LV) wall + septum) thickness >12mm as measured by echocardiography in absence of other known cause of left ventricular hypertrophy (LVH), - NT-proBNP >335 ng/L
- •Planned diagnostic procedures to establish diagnosis and cardiac involvement (e.g., endomyocardial biopsy or extracardiac biopsy in conjunction with cardiac magnetic resonance imaging/ echocardiography or bone scintigraphy)
- •Female subjects must be documented by medical records or physician’s note to be either surgically sterile (by means of hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or post-menopausal for at least 1 year (no menses for 12 months without an alternative medical cause). If they are of child-bearing potential, they must commit to use of a highly effective contraceptive measure for one week after the PET scan (including combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence).
- •Male subjects and their partners of childbearing potential must commit to the use of a highly effective method of contraception for a minimum of 90 days following each PET scan (including, for female partners of childbearing potential, combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, male subjects with vasectomy or sexual abstinence).
- •Male subjects must commit to not donate sperm for a minimum of 90 days after the PET scan
排除标准
- •Any known allergic reactions or hypersensitivity towards any compound of the study drug
- •Severe hepatic impairment (AST/ALT >5 x ULN; bilirubin >3 x ULN)
- •Inability to lay flat for up to 60 min
- •Pregnant, lactating or breastfeeding
- •Unwilling and/or unable to cooperate with study procedures
- •Having been administered a PET radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study
结局指标
主要结局
The co-primary efficacy variables will be the sensitivity and specificity of the visual assessment of [18F]florbetaben PET images for the diagnosis of cardiac AL amyloidosis
The co-primary efficacy variables will be the sensitivity and specificity of the visual assessment of [18F]florbetaben PET images for the diagnosis of cardiac AL amyloidosis
次要结局
- The sensitivity and specificity of [18F]florbetaben PET for the diagnosis of cardiac AL amyloidosis will be determined by using quantitative image analysis
- Correlation of quantitative [18F]florbetaben PET results with left ventricular ejection fraction (LV EF) and left ventricular mass (LV mass)
- Correlation of quantitative [18F]florbetaben PET results with AL-CA prognostic values (Mayo stage I – IV) based on FLC-diff, cTnT and NT-proBNP levels.
- The impact of PET imaging (AL-CA/non AL-CA) on diagnostic thinking and patient management will be assessed with physician’s questionnaires before and after the diagnostic work-up, and after receipt of the PET results
研究者
Clinical Trial Information desk
Scientific
Life Molecular Imaging GmbH
研究点 (11)
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