CETO First in Human Trial

NCT04529018 | Unknown DMC

• 3 other identifiers: CETO-FIH2018-004851-18ISRCTN16159564
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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 lateralisation of primary aldosteronism (PA).

Conditions

Primary Aldosteronism

Keywords

Adrenal; Conn's; Endocrine; Aldosterone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• [18F]CETO uptake by the the adrenal glands.

  6 months

• To evaluate uptake in bilateral versus unilateral cases of PA following [18F]CETO administration in up to 6 patients.

  6 months

Study Arms (2)

Healthy Volunteers

EXPERIMENTAL

A group of 5 healthy volunteers will be tested with the PET radiotracer \[18F\]CETO to assess safety of tracer administration, and evaluate uptake by the normal adrenal glands.

Combination Product: [18F]CETO

Patients with primary aldosteronism

EXPERIMENTAL

A group of 6 patients with Primary Aldosteronism (3 with unilateral and 3 with bilateral disease) will be tested with up to two administrations of the PET radiotracer \[18F\]CETO, to assess safety of tracer administration, evaluate the ability of \[18F\]CETO to distinguish between unilateral and bilateral cases of PA, and determine the effect of Dexamethasone in improving the quality of PET-CT images acquired following administration.

Combination Product: [18F]CETO

Interventions

[18F]CETO COMBINATION_PRODUCT

\[18F\]CETO is a PET radiotracer used to diagnose and visualise the cause(s) of primary aldosteronism

Also known as: CETO

Healthy Volunteers; Patients with primary aldosteronism

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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
• \- allergy or contraindication to dexamethasone treatment (or lactose intolerant)

Sponsors & Collaborators

• University of Cambridge: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Addenbrooke' Hospital

Cambridge, Cambridgeshire, CB20QQ, United Kingdom

RECRUITING

Related Publications (3)

• 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.

  PMID: 22112805 BACKGROUND

• 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.

  PMID: 18397978 BACKGROUND

• Bergstrom M, Juhlin C, Bonasera TA, Sundin A, Rastad J, Akerstrom G, Langstrom B. PET imaging of adrenal cortical tumors with the 11beta-hydroxylase tracer 11C-metomidate. J Nucl Med. 2000 Feb;41(2):275-82.

  PMID: 10688111 BACKGROUND

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Mark Gurnell, PhD, FRCP

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Thomas, PhD

CONTACT

01223 254 920; martin.thomas@addenbrookes.nhs.uk

Russell Senanayake, MRCP, MSc

CONTACT

01223 348 739; russell.senanayake@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Scans will be assessed by two independent nuclear medicine physicians, who will be blinded to patient identifiable data when analysing PET-CT scans.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Clinical Endocrinology and Honorary Consultant

Model Details: Phase I single-centre, open-label, micro-dosing study

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 27, 2020
• Study Start: August 3, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: August 27, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)