Primary aldosteronism Nutritional, Metabolic, Endocrine
Conditions
Interventions
All participants receive a single intravenous bolus injection of [18F]AldoView as a sterile injectable solution at a dose of 200 ± 20 MBq (up to and including 10 micrograms non-radioactive compound).
Sponsors
University College London
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: General criteria (all participants): 1. Age =18 years at the time of consent. 2. Able and willing to give informed consent, including literate and sufficiently fluent in English to understand written and verbal information about the trial. 3. Women of childbearing potential must agree to use a highly effective method of contraception from consent until completion of the safety follow-up call (Day 4–8 post-dose). 4. Male participants should use condoms during the study and for at least 8 days after dosing unless otherwise justified. Willing and able to comply with all trial procedures, including PET-CT imaging, safety assessments, and follow-up as required. Primary aldosteronism group: 1. Confirmed diagnosis of primary aldosteronism, established according to Endocrine Society-aligned standard-of-care diagnostic criteria, including: 1.1. Suppressed renin with inappropriately elevated aldosterone and/or elevated aldosterone-to-renin ratio, with confirmatory testing where required. 1.2. Participants undergoing standard-of-care diagnostic evaluation and subtyping for primary aldosteronism, including: 1.2.1. AVS performed within the previous 3 years or scheduled as part of standard clinical care, or 1.2.2. Eligibility for exemption from AVS according to recognised clinical guidelines (e.g., younger patients with clear unilateral disease on imaging). 2. Participants considered potential candidates for surgical or medical management of primary aldosteronism as part of routine clinical care. 3. Willingness to allow access to relevant medical records, including biochemical results, imaging, AVS findings, operative reports, and follow-up outcome data. 4. For participants undergoing adrenalectomy as part of standard care, willingness to allow use of resected adrenal tissue for histopathological and immunohistochemical assessment (CYP11B2 staining), which is essential for the primary endpoint. Control groups (PA-negative): 1. Healthy volunteers with no evidence of primary aldosteronism or significant adrenal disease, confirmed by screening assessments. 2. Participants with adrenal disorders other than primary aldosteronism, in whom PA has been excluded by normal aldosterone and renin testing as part of standard care. 3. Control participants must not have biochemical or clinical evidence of primary aldosteronism at the time of enrolment. 4. WOCP must be willing to use a highly effective contraception.
Exclusion criteria
Exclusion criteria: 1. Unable to provide written informed consent 2. Allergy to contrast agents 3. Current use of aldosterone synthase inhibitor 4. Severe renal and hepatic failure 5. Unwilling to use effective contraception until safety follow-up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correct Localisation Rate (CLR), defined as the proportion of participants with correct localisation of the affected adrenal gland, determined by concordance between [18F]AldoView PET-CT findings and post-surgical CYP11B2 immunohistochemical (IHC) staining. [18F]AldoView PET-CT is performed on Day 1 and interpreted by blinded readers, and results are compared with CYP11B2 IHC staining of resected adrenal tissue obtained at adrenalectomy (reference standard). CLR is assessed once both PET-CT and IHC results are available for each participant, with final analysis conducted at study completion in participants with evaluable PET-CT and conclusive IHC results. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The safety and tolerability of a single intravenous dose of [18F]AldoView, assessed by the incidence of treatment-emergent adverse events (TEAEs). The variable measured is the occurrence of one or more TEAEs. TEAEs are recorded from the time of intravenous administration of [18F]AldoView until completion of the scheduled safety follow-up call conducted between Day 4 and Day 8 post-dose. 2. The diagnostic accuracy of [18F]AldoView PET-CT for detecting primary aldosteronism (PA). The variables measured are positive percent agreement and negative percent agreement of [18F]AldoView PET-CT relative to the reference diagnosis of PA (PA-positive or PA-negative). PET-CT imaging is performed on Day 1 and interpreted by blinded readers, and results are compared with the reference diagnosis. Diagnostic accuracy is assessed once both PET-CT and reference diagnostic results are available for each participant, with final analysis conducted at study completion. Exploratory outcomes: 1. The ability of [18F]AldoView PET-CT to predict the outcome of adrenalectomy in participants with PA. The variables measured are the sensitivity and specificity of PET-CT for predicting biochemical and clinical cure. PET-CT scans performed on Day 1 are interpreted by the trial multidisciplinary team (MDT), and findings are compared with post-operative outcomes classified according to the Primary Aldosteronism Surgical Outcome (PASO) criteria. Postoperative biochemical and clinical outcomes are assessed according to PASO at the scheduled post-surgical follow-up visits (6 and 12 months), and predictive accuracy is determined once both PET-CT interpretations and PASO-defined outcomes are available for each participant, with final analysis conducted at study completion. 2. The biodistribution and radiation dosimetry of [18F]AldoView. The variable measured is the effective radiation dose (mSv per MBq administered). Dosimetry is derived from whole-body PET-CT scans performed in four participants from t | — |
Countries
England, United Kingdom
Contacts
Public ContactAndrew Tunstell
Outcome results
None listed