Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
6936
Study information
Scientific title
Hypertension due to Conn's adenoma - the localisation of adrenal cortical adenomas by 11C-metomidate PET scanning following dexamethasone and fludrocortisone suppression
Acronym
Study hypothesis
In order to ensure appropriate treatment, it is important to be able to identify Conn's adenoma reliably from other adrenal conditions. Current identification techniques, such as adrenal venous sampling, are time consuming, often invasive and probematic making treatment decisions difficult. It is proposed that non-invasive PET/CT scanning using 11C-metomidate as a radiomarker will identify people with Conn's adenoma as well as currently used invasive techniques.
More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=6936
Ethics approval
Cambridgeshire 4 Research Ethics Board, 12/05/2008, ref: 08/H0305/20
Study design
Single-centre non-randomised treatment trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Metabolic and Endocrine; Subtopic: Metabolic and Endocrine (all Subtopics); Disease: Metabolic & Endocrine (not diabetes)
Intervention
In addition to standard investigations for suspected Conn's adenoma, each participant will undergo a positron emission tomography (PET)/computed tomography (CT) scan with intravenous 11C-metomidate (500 MBq) as a radio-label. The first 6 participants will undergo 3 scans to evaluate which suppression protocol produces the clearest image:
1. Without any additional drug therapies
2. Oral 0.5 mg dexamethosone 6-hourly for 48 hours prior to scan
3. Oral 0.5 mg dexamethosone 6-hourly for 48 hours prior to scan with the addition of 400 µg of fludrocortisone for 3 days prior to the scan
Intervention type
Other
Phase
Phase IV
Drug names
Primary outcome measure
The sensitivity of 11C-metamidate PET/CT scanning for detecting Conn's adenoma
Secondary outcome measures
1. The specificity of 11C-metomidate PET/CT scanning for detecting Conn's Syndrome
2. To determine the suppression protocol that leads to the best sensitivity of 11C-metomidate PET/CT scanning for detecting Conn's Syndrome
Overall trial start date
17/04/2009
Overall trial end date
30/04/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male or female
2. Aged 18 years or over
3. Suspected Conn's syndrome or suspected adrenal hyperplasia or healthy with non-functional adenoma
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned sample size: 50
Participant exclusion criteria
1. Inability to give informed consent
2. Heart failure
3. Women of childbearing potential not using contraception
4. Pregnant or breast feeding women
Recruitment start date
17/04/2009
Recruitment end date
30/04/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom
Sponsor information
Organisation
Cambridge University Hospitals NHS Foundation Trust (UK)
Sponsor details
Addenbrooke's Hospital
Box 277
Hills Road
Cambridge
CB2 2QQ
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation (BHF) (UK)
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22112805