A Phase III Study of [11C]-DMDPA Tracer for Positron Emission Tomography PET-CT Myocardial Perfusion Imaging (MPI).

Synektik Spólka Akcyjna0 个研究点目标入组 350 人开始时间: 2021年9月15日最近更新: 2024年8月26日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 350

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1.Male and female subjects at least 18 years of age at the moment of start of the screening
•2.At the time of first dosing of the study product in the study the subject is at the earliest 30 days after onset of acute coronary syndrome (ACS) which met the ECS definition of ACS,
•3.The subject is able to understand the study concept and provide written consent to it, and has agreed to participate in the study, read, signed and dated the informed consent form (ICF) prior to any study procedures being performed,
•4.The subject is able and willing to comply with all study procedures as described in the protocol.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 130
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 220

排除标准

•1.Life expectancy < 1 year.
•2.BMI=32.5
•3.Active or with high risk of recurrence, as per Investigator’s judgment, oncological condition except for basal cell skin cancer.
•4.Subject exposed to radiation >6mSv within 12 months prior to the study PET-CT imaging or known or expected need for >6mSV radiation-involving procedures or exposures other than the study PET-CT.
•5.Known cardiovascular medical history and conditions or past or future procedures deemed particularly important from the study perspective:
•Past results of left ventricular ejection fraction (LVEF) <40%
•Past, current, or planned cardiac surgical treatment including e.g. coronary angioplasty, stents, by-pass, during the participation in the study
•Three or more ACS episodes in the past
•Known at the time of screening, planned, early revascularization
•Poorly controlled hypertension with blood pressure over 180/100 mmHg despite medications, during period between ACS and Screening to this study
•Systolic blood pressure below 100 mmHg measured shortly before PET-CT MPI
•Acute, clinically relevant changes in electrocardiogram (ECG) in comparison to the most recent ECG
•NYHA Class III or IV Congestive heart failure
•known non-ischemic cardiomyopathy or significant valvular heart disease as judged by the investigator
•symptomatic hypotension as per Investigator’s judgment
•severe or otherwise clinically significant cardiac arrhytmias including atrial fibrillation, which could significantly influence risk of major cardiac events regardless of myocardial perfusion’s quality, as per Investigator’s judgment
•other cardiovascular condition which is an absolute contraindication to the PET-CT-MPI procedure
•diagnosed carotid artery stenosis 60% or higher
•recent or unresolved myocarditis
•ischemic stroke in the past (except for TIA or small-size strokes which occurred >10 years ago and recovered leaving no neurologic deficit),
•pulmonary embolism within last 5 years
•long QT syndrome or QTcB>470 in males and >480 ms in females
•recent myocardial infarction in the context of precautions for regadenoson administration, per Investigator’s judgment
•6. History of seizures or other risk factors for seizures, including the concomitant administration of medicinal products that lower seizure threshold in the context of precautions for regadenoson administration, per Investigator’s judgment.
•7. Inability to lie still for the test.
•8. Smoking equivalent of 10 or more cigarettes/day.
•9. Need for anticoagulant treatment except for prophylactic doses of ASA as judged by the investigator.
•10. Active severe inflammatory condition as judged by the Investigator.
•11. Permanent use of systemic corticosteroids with dose equivalent to >10mg/day of prednisone.
•12. Need for regular use of strong immunosuppressive medications (e.g. cyclosporine, methotrexate etc.) or chemotherapy, as judged by the investigator.
•13. Past, recent or current daily use of medications with known strong cardiotoxic side effects as judged by the investigator.
•14. Conditions which involve bronchospasm
•15. Diabetes type 1 or another type of diabetes requiring use of insulin.
•16. Serum creatinine > 2 mg/dL.
•17. Anemia, grade II or worse (according to CTCAE v.5.0 classification).
•18. Any exposure to any investigational product(s), drug(s) or medical device(s) within four weeks prior to the study imaging procedure.
•19.Any clinically significant, acute or unstable physical, psychiatric or psychological disease/condition

研究者

发起方

Synektik Spólka Akcyjna

相似试验

已完成

1 期

A Phase I Study of a Novel Tracer for Positron Emission Tomography "PET" Myocardial Perfusion Imaging "MPI"Coronary Artery Disease

NCT02720354Synektik S.A.12

进行中（未招募）

1 期

Diagnostic performance of [18F]CTT1057 PET in BCRProstate cancer with rising PSA levels [biochemical recurrence (BCR)]MedDRA version: 21.0Level: PTClassification code 10036911Term: Prostate cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2020-003959-16-ESovartis Farmacéutica S.A.190

进行中（未招募）

1 期

EUCTR2020-003959-16-FRovartis Pharma AG190

招募中

不适用

Biomarker study of "A Phase III Trial of Docetaxel plus S-1 versus S-1 Alone in the Treatment of Curatively Resected Stage III Gastric Cancer (JACCRO GC-07(START-2))"Gastric cancer

JPRN-UMIN000031675Japan Clinical Cancer Research Organization (JACCRO)800

进行中（未招募）

1 期

A study of Positron/Computerized Tomography (PET/CT) with 18F-PSMA1007 versus 18F-Choline to compare the detection rate of prostate cancer relapse after definite treatmentProstate cancer recurrentMedDRA version: 21.0 Level: PT Classification code 10036911 Term: Prostate cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

EUCTR2019-001302-15-GRBIOKOSMOS S.A.190