A Phase I clinical trial evaluating the safety and efficacy of up to two administrations of the adrenal PET tracer [18F]CETO in healthy volunteers and patients with primary aldosteronism

Cambridge University Hospitals NHS Foundation Trust0 个研究点目标入组 11 人开始时间: 2020年5月19日最近更新: 2023年1月9日

适应症

试验速览

暂无简介。

•Healthy volunteers:
•To be included in the trial the participant must:
•1. Give written informed consent
•2. Be aged 50 years or over
•3. Have no underlying medical conditions
•4. Be able to lie down for at least 2 hours and not be claustrophobic
•In addition, all female participants must be:
•1. Post-menopausal (no menses for 12 months, without an alternative medical cause)
•To be included in the trial the patient must:
•1. Give written informed consent
•2. Be aged 40 years or over
•3. Be able to lie down for at least 2 hours and not be claustrophobic
•4. Fulfil the following criteria:
•4.1. Have a confirmed diagnosis of PA as per Endocrine Society guidelines*
•4.2. Have undergone successful lateralisation of the cause of PA to one or both adrenal glands by adrenal vein sampling (AVS).
•4.3. Be willing to have two scans
•In addition, all female patients must have a negative (blood) pregnancy test at the screening visit
•*Endocrine Society guidelines are:
•1. At least one paired measurement of plasma renin and aldosterone, measured off Spironolactone/Eplerenone within past 12 months, showing ARR above local threshold value
•2. One of the following two criteria:
•2.1. Plasma aldosterone > 190 pmol/L following saline infusion
•2.2. Spontaneous hypokalaemia, suppressed plasma renin and plasma aldosterone > 550 pmol/L

•All participants:
•1. Allergy to radiographic contrast agents
•2. Allergy or contraindication to synacthen
•3. Pregnancy, breastfeeding, or the intention to become pregnant during the 6 months following trial participation
•4. Positive pregnancy test at the screening or baseline visits
•5. Assessed by the investigator as being unable or unwilling to comply with the requirements of the study protocol.
•6. Receipt of another IMP as part of a CTIMP
•7. Prior radiation exposure as part of previous research studies
•8. Recreational drug use, or substance/alcohol dependency
•9. Clinically abnormal screening blood tests [including abnormal short synacthen test]
•Additional exclusion criteria for healthy volunteers:
•1. Women of child-bearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy)
•2. Exposure to radiation during their work
•3. Received more than 10 mSv of radioactivity in the past 12 months
•4. Any subject with a history of adrenal disease or who, at the screening visit, reports symptoms, or exhibits physical signs, that could be consistent with previously unsuspected adrenal disease
•Additional exclusion criteria for patients:
•1. Allergy or contraindication to dexamethasone treatment (or lactose intolerant)

发起方