A first-in-human safety study of the novel adrenal PET tracer [18F]CETO

Phase 1

Completed

• Conditions: Primary aldosteronism; Nutritional, Metabolic, Endocrine; Primary hyperaldosteronism

• Registration Number: ISRCTN16159564
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-19
• Study Completion: 2020-11-20
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 11

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified