Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:38 AM
Ignite Modification Date:
2025-12-25 @ 4:38 AM
NCT ID:
NCT04529018
Eligibility Criteria:
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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04529018
Study Brief:
Protocol Section:
NCT04529018