ISRCTN16159564
Completed
Phase 1
A Phase I 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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Primary aldosteronism
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Enrollment
- 11
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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)
- •To be included in the trial the patient must:
- •1\. Give written informed consent
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]
Outcomes
Primary Outcomes
Not specified
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