11C- metomidate positron emission tomography (PET) scanning for Conn's syndrome
| ISRCTN | ISRCTN58267591 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58267591 |
| Secondary identifying numbers | 6936 |
- Submission date
- 12/05/2010
- Registration date
- 12/05/2010
- Last edited
- 02/06/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Timothy J. Burton
Scientific
Scientific
Clinical Pharmacology Unit
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Study information
| Study design | Single-centre non-randomised treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Hypertension due to Conn's adenoma - the localisation of adrenal cortical adenomas by 11C-metomidate PET scanning following dexamethasone and fludrocortisone suppression |
| Study objectives | 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(s) | Cambridgeshire 4 Research Ethics Board, 12/05/2008, ref: 08/H0305/20 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 17/04/2009 |
| Completion date | 30/04/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned sample size: 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 17/04/2009 |
| Date of final enrolment | 30/04/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Addenbrooke's Hospital
Cambridge
CB2 0QQ
United Kingdom
CB2 0QQ
United Kingdom
Sponsor information
Cambridge University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Addenbrooke's Hospital
Box 277, Hills Road
Cambridge
CB2 2QQ
England
United Kingdom
| Website | http://www.cuh.org.uk/research/research_index.html |
|---|---|
"ROR" |
https://ror.org/04v54gj93 |
Funders
Funder type
Charity
British Heart Foundation (BHF) (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- the_bhf, The British Heart Foundation, BHF
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2012 | Yes | No |
