Condition category
Nutritional, Metabolic, Endocrine
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
02/06/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Timothy J. Burton

ORCID ID

Contact details

Clinical Pharmacology Unit
Hills Road
Cambridge
CB2 0QQ
United Kingdom

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 measures

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

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

http://www.cuh.org.uk/research/research_index.html

Funders

Funder type

Charity

Funder name

British Heart Foundation (BHF) (UK)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22112805

Publication citations

Additional files

Editorial Notes