Primary Aldosteronism Clinical Trial
— CETOOfficial title:
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
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).
Status | Recruiting |
Enrollment | 11 |
Est. completion date | November 30, 2020 |
Est. primary completion date | November 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Addenbrooke' Hospital | Cambridge | Cambridgeshire |
Lead Sponsor | Collaborator |
---|---|
University of Cambridge | Cambridge University Hospitals NHS Foundation Trust |
United Kingdom,
Bergström M, Juhlin C, Bonasera TA, Sundin A, Rastad J, Akerström G, Långström B. PET imaging of adrenal cortical tumors with the 11beta-hydroxylase tracer 11C-metomidate. J Nucl Med. 2000 Feb;41(2):275-82. — View Citation
Burton TJ, Mackenzie IS, Balan K, Koo B, Bird N, Soloviev DV, Azizan EA, Aigbirhio F, Gurnell M, Brown MJ. Evaluation of the sensitivity and specificity of (11)C-metomidate positron emission tomography (PET)-CT for lateralizing aldosterone secretion by Conn's adenomas. J Clin Endocrinol Metab. 2012 Jan;97(1):100-9. doi: 10.1210/jc.2011-1537. Epub 2011 Nov 23. — View Citation
Hahner S, Stuermer A, Kreissl M, Reiners C, Fassnacht M, Haenscheid H, Beuschlein F, Zink M, Lang K, Allolio B, Schirbel A. [123 I]Iodometomidate for molecular imaging of adrenocortical cytochrome P450 family 11B enzymes. J Clin Endocrinol Metab. 2008 Jun;93(6):2358-65. doi: 10.1210/jc.2008-0050. Epub 2008 Apr 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of [18F]CETO administration | 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. | 6 months | |
Secondary | [18F]CETO uptake by the the adrenal glands. | [18F]CETO uptake by the adrenal glands will be 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. | 6 months | |
Secondary | To evaluate uptake in bilateral versus unilateral cases of PA following [18F]CETO administration in up to 6 patients. | Evaluation of adrenal uptake of [18F]CETO in bilateral versus unilateral cases of PA will be performed by comparing SUV values of both adrenal glands in three patients with each subtype of PA (using a dedicated blinded reviewer). | 6 months |
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