Rubidium-82 PET and Tc-99m-MIBI SPET: A Head to Head Comparison | Completed
Rubidium-82 PET and Tc-99m-MIBI SPET: A Head to Head Comparison

Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Coronary Artery Disease
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01379677
Primary Trial ID Number
Summary
The main purpose of this study is to compare myocardial perfusion imaging using Rubidium-82 PET with Tc-99m-MIBI SPET, in the evaluation of significant Coronary Artery Disease (CAD).
Research Details
    Sorry, this information is not available
Phase
Phase 3
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Study Type
Interventional
Intervention
Drug : Rubidium-82, Drug : Sestamibi. reconstitution with sodium pertechnetate (99mTc)

Study Arm Groups : Single arm, Single arm

Intervention Type
See Interventions above
Primary Outcome Measures
  • The specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography); Up to 2 days
Secondary Outcome Measures
  • Evaluate any difference in the clinical interpretation of the Rubidium-82 PET and Tc-99m-MIBI SPET images.; Up to 2 days; Evaluate any difference in "Percentage myocardium" that is hypoperfused, between Rubidium-82 PET and Tc-99m-MIBI SPET.; Up to 2 days; Evaluate any difference in image quality, artefacts and interpretative confidence between Rubidium-82 PET and Tc-99m-MIBI SPET.; Up to 2 days; Evaluate any adverse events or reactions, during Rubidum-82 or Tc-MIBI administration.; Up to 2 days
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
40 Years - N/A
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - Referred for scintigraphy to assess myocardial ischaemia
  • - Ability to give informed written consent.
  • Exclusion Criteria:
  • - Impaired capacity to consent
  • - Pregnancy, or breastfeeding
  • - Allergy to iv contrast
  • - Renal failure
  • - Severe Uncontrolled asthma
  • - Claustrophobia
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
University College London
London
NW1 2BU
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
Scientific Title
Diagnosis of Coronary Artery Disease With Rubidium-82 PET and Technetium-99m-MIBI SPET: A Head to Head Comparison, Versus Coronary CT Angiography
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
2009Rb82UK
Sponsor(s)
Advanced Accelerator Applications
Key Dates

Recruitment Start Date

Feb 2011

Recruitment End Date

Nov 2013

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

09 Jun 2011

Last Updated

13 May 2014