A Phase 1 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
试验速览
- 阶段
- 不适用
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Safety of [18F]CETO administration
研究概览
简要总结
The study is a Phase 1, single-centre, open label, micro-dosing study. The aim is to investigate an innovative new tracer, [18F]CETO, as a potential alternative to adrenal vein sampling for the lateralisation of primary aldosteronism (PA).
详细描述
At least one-quarter of the UK adult population has hypertension, a major risk factor for heart attacks and stroke. Primary aldosteronism (PA), a treatable form of hypertension, accounts for 5-10% of all cases, and 20-25% of difficult to control hypertension. It is challenging to determine whether one adrenal gland is the source of PA (which is potentially curable with surgery) or both glands (which would require long-term drug treatment). Existing lateralising procedures (i.e. investigations to distinguish one from two gland involvement e.g. CT or MRI scan) have significant limitations. Accordingly, most patients must undergo an invasive procedure called adrenal vein sampling (AVS) in which small catheters are placed in each adrenal vein. However, this is time-consuming, technically demanding, and fails in 20-50% of cases. To address this, researchers have adopted a novel approach using PET-CT as an alternative to AVS. Currently, this uses a tracer called metomidate labelled with carbon-11 (11C MTO), which is taken up preferentially by the adrenal gland, and in particular by adrenal tumours causing PA. However, its utility is limited by a short half-life, which means the scan can only be performed in centres with a cyclotron facility (currently less than 10 NHS sites). The aim of this study is to investigate the safety of a new tracer with a longer half-life, [18F]CETO, that could be made available for use in many more centres.
The trial objectives are outlined below:
Primary Objective
To evaluate the safety of up to two administrations of [18F]CETO in up to 6 patients with primary aldosteronism and 5 healthy volunteers.
Secondary Objective
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Scans will be assessed by two independent nuclear medicine physicians, who will be blinded to patient identifiable data when analysing PET-CT scans.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •All participants:
- •allergy to radiographic contrast agents
- •allergy or contraindication to synacthen
- •pregnancy, breastfeeding, or the intention to become pregnant during the 6 months following trial participation
- •positive pregnancy test at the screening or baseline visits
- •assessed by the investigator as being unable or unwilling to comply with the requirements of the study protocol.
- •receipt of another IMP as part of a CTIMP
- •prior radiation exposure as part of previous research studies
- •recreational drug use, or substance/alcohol dependency
- •clinically abnormal screening blood tests.
- •Additional exclusion criteria for healthy volunteers:
- •women of child-bearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile)
- •exposure to radiation during their work
- •received more than 10 mSv of radioactivity in the past 12 months
- •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:
- •allergy or contraindication to dexamethasone treatment (or lactose intolerant)
结局指标
主要结局
Safety of [18F]CETO administration
时间窗: 6 months
The primary outcome measure is the overall safety of \[18F\]CETO. This will be assessed according to the frequency of adverse events, serious adverse events, clinically significant changes in vital signs, ECG and laboratory parameters.
次要结局
- [18F]CETO uptake by the the adrenal glands.(6 months)
- To evaluate uptake in bilateral versus unilateral cases of PA following [18F]CETO administration in up to 6 patients.(6 months)
研究者
Professor Mark Gurnell
Professor in Clinical Endocrinology and Honorary Consultant
University of Cambridge