Status:
UNKNOWN
CETO First in Human Trial
Lead Sponsor:
University of Cambridge
Collaborating Sponsors:
Cambridge University Hospitals NHS Foundation Trust
Conditions:
Primary Aldosteronism
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
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 late...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Healthy Volunteers
- To be included in the trial the participant must:
- give written informed consent
- be aged 50 years or over
- have no underlying medical conditions
- be able to lie down for at least 2 hours and not be claustrophobic
- In addition, all female participants must be:
- \- post-menopausal (no menses for 12 months, without an alternative medical cause)
- Patients
- To be included in the trial the patient must:
- give written informed consent
- be aged 40 years or over
- be able to lie down for at least 2 hours and not be claustrophobic
- fulfil the following criteria:
- have a confirmed diagnosis of PA as per Endocrine Society guidelines
- At least one paired measurement of plasma renin and aldosterone, measured off Spironolactone/Eplerenone within past 12 months, showing ARR above local threshold value.
- One of the following two criteria:
- Plasma aldosterone\>190pmol/L following saline infusion.
- Spontaneous hypokalaemia, suppressed plasma renin and plasma aldosterone\>550pmol/L.
- have undergone successful lateralisation of the cause of PA to one or both adrenal glands by adrenal vein sampling (AVS).
- be willing to have two scans
- In addition, all female patients must have a negative (blood) pregnancy test at the screening visit.
- Exclusion Criteria:
- 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)
Exclusion
Key Trial Info
Start Date :
August 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2020
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04529018
Start Date
August 3 2020
End Date
November 30 2020
Last Update
August 27 2020
Active Locations (1)
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1
Addenbrooke' Hospital
Cambridge, Cambridgeshire, United Kingdom, CB20QQ