Primary aldosteronism Nutritional, Metabolic, Endocrine Primary hyperaldosteronism
Conditions
Interventions
This study will investigate the administration of a small dose of a PET radiotracer in a single centre, with participants being made aware of the type of tracer being administered. The study is design
Sponsors
Cambridge University Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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) Patients: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of [18F]CETO measured according to the frequency of adverse events, serious adverse events, clinically significant changes in vital signs, ECG and laboratory sampling; assessed at the conclusion of trial participation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. [18F]CETO uptake by the adrenal glands assessed by measurement of Standardized Uptake Values (SUV) over the left and right adrenal glands: all assessments will be performed by a dedicated blinded reviewer; assessed at each of up to two PET-CT scans 2. Adrenal uptake of [18F]CETO in bilateral versus unilateral cases of PA performed by comparing SUV values of both adrenal glands in three patients with each subtype of PA (using a dedicated blinded reviewer); assessed at each of up to two PET-CT scans | — |
Countries
England, United Kingdom
Outcome results
None listed