2023-505569-95-00招募中4 期
A Phase 4, Open-Label, Non-randomised, Multicentre Study to Evaluate Safety and Efficacy of Intravenous Administration of Sonazoid™ for Contrast-Enhanced Ultrasound Liver Imaging in Paediatric Patients.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- The accuracy, sensitivity and specificity of the diagnosis based on the independent blinded read of the Sonazoid™-enhanced imaging for lesion differentiation (benign or malignant FLLs) during vascular phase imaging. The WFUMB-EFSUMB guidelines for interpreting CEUS of the liver in adults shall be used for interpreting the images and the subject’s baseline diagnosis (well-established by CECT, CEMRI or biopsy) will be used as the reference diagnosis/standard of truth.
研究概览
简要总结
To evaluate the diagnostic accuracy of ultrasound images enhanced with Sonazoid™ (perflubutane microbubbles) for differentiating benign vs malignant focal liver lesions (FLL) in paediatric patients during vascular phase imaging.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
入选标准
- •The subject is <18 years of age on the day of consent.
- •The subject has at least 1 untreated FLL with ≤8 lesions (excluding cysts), with ≤8 cm confirmed in a diagnostic examination performed in the past month (or past 3 months if the lesion was benign) and that could also be visualised when obtained via unenhanced ultrasound imaging.
- •The subject has had a dynamic CECT or CEMRI examination within the past month for malignant lesions, or 3 months for benign lesions if performed retrospectively, or is scheduled to have one in the month following inclusion in the study, and these images are/would be available.
- •The subject can comply with study procedures.
- •Parents or legally authorised representatives have signed the Informed Consent Form approved for this study by the Independent Review Board (IRB)/Independent Ethics Committee (IEC). The form will indicate that the patient (and/or a legally acceptable representative) has been informed of all pertinent aspects of the study. Patients who are able to provide assent have signed an age-appropriate paediatric assent form
- •Post-menarcheal female patients must have a negative urine pregnancy test at screening and at pre-dose on the dosing day.
- •Post-menarcheal female patients and male patients who are sexually active with a partner of childbearing potential must be practicing abstinence or be using an effective form of birth control (See Section 8.6) for ≥30 days before being enrolled in the study.
- •The subject has a body weight of 3 kg or greater.
- •The subject has a negative egg allergy test if the egg allergy status of the subject is unknown.
排除标准
- •The subject has a known or suspected hypersensitivity to any of the components of Sonazoid™, including a history of allergies to eggs or egg products (i.e., manifested by full body rash, respiratory difficulty, oral or laryngeal swelling, hypotension, or shock), or a positive result from an egg-allergy test performed at screening. Note: If the egg-allergy status is unknown, an egg-allergy test must be performed at screening and the result must be negative.
- •The subject has an acute clinically fatal condition (i.e., the expected survival is ≤6 months).
- •The subject has previously received Sonazoid™ or another ultrasound contrast agent within the past 30 days.
- •The subject had undergone or is planning to undergo an examination with a contrast agent (i.e., iodinated x-ray contrast agent, MRI contrast agent or another ultrasound contrast agent) within the 24 hours before or after Sonazoid™ injection.
- •The subject has undergone or was undergoing systemic or loco-regional chemotherapy or radiation therapy.
- •The subject is participating in another clinical trial with an unregistered medicinal product, or less than 30 days has passed since the subject completed participation in such a trial.
- •The subject is a pregnant or lactating female.
- •The physician judges that a large-enough needle (24-gauge or larger) cannot be inserted.
- •The subject has a known right-left cardiac shunt.
结局指标
主要结局
The accuracy, sensitivity and specificity of the diagnosis based on the independent blinded read of the Sonazoid™-enhanced imaging for lesion differentiation (benign or malignant FLLs) during vascular phase imaging. The WFUMB-EFSUMB guidelines for interpreting CEUS of the liver in adults shall be used for interpreting the images and the subject’s baseline diagnosis (well-established by CECT, CEMRI or biopsy) will be used as the reference diagnosis/standard of truth.
The accuracy, sensitivity and specificity of the diagnosis based on the independent blinded read of the Sonazoid™-enhanced imaging for lesion differentiation (benign or malignant FLLs) during vascular phase imaging. The WFUMB-EFSUMB guidelines for interpreting CEUS of the liver in adults shall be used for interpreting the images and the subject’s baseline diagnosis (well-established by CECT, CEMRI or biopsy) will be used as the reference diagnosis/standard of truth.
次要结局
- Accuracy, sensitivity and specificity of the diagnosis (benign or malignant FLL) based on the Sonazoid™-enhanced imaging by vascular phase imaging, as compared with the unenhanced ultrasound imaging, when the baseline diagnosis is used as the reference standard.
- Accuracy, sensitivity and specificity of the diagnosis (benign or malignant FLL) based on the Sonazoid™-enhanced imaging by vascular phase and Kupffer phase imaging, as compared with the unenhanced ultrasound imaging, when the baseline diagnosis is used as the reference standard.
- The difference in the diagnostic confidence score for the unenhanced ultrasound imaging and that for the Sonazoid™-enhanced ultrasound imaging based on the vascular phase.
- Exploratory outcome measure: The difference in the diagnostic confidence score for the unenhanced ultrasound imaging and that for the Sonazoid™-enhanced ultrasound imaging based on the vascular and Kupffer phase.
- Exploratory outcome measure: CEUS specific FLL diagnosis throughout the vascular phase of imaging and the vascular and Kupffer phases of imaging according to WFUMB-EFSUMB guidelines (HCC, metastasis, haemangioma, FNH, focal fatty infiltration, focal fatty sparing) observed in paediatric patients.
- Safety outcome measure: Treatment-emergent AEs (TEAEs) defined as AEs that occurred at any timepoint from the administration of Sonazoid™ to the end of the study (72 hours after Sonazoid™ administration), including drug-related TEAEs
- Safety outcome measure: Serious AEs (SAEs)
- Safety outcome measure: Physical examination, vital signs, blood and urine samples for clinical laboratory testing and injection site monitoring
研究者
David Thompson
Scientific
GE Healthcare Limited
研究点 (3)
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