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

Coronary Artery Disease Clinical Trial

Official title:

Diagnosis of Coronary Artery Disease With Rubidium-82 PET and Technetium-99m-MIBI SPET: A Head to Head Comparison, Versus Coronary CT Angiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01379677
• Other study ID #: 2009Rb82UK
• Secondary ID: 2009-016645-25
• Status: Completed
• Phase: Phase 3
• First received: June 9, 2011
• Last updated: May 13, 2014
• Start date: February 2011
• Est. completion date: November 2013

Study information

• Verified date: May 2014
• Source: Advanced Accelerator Applications
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Rubidium-82
Maximum dose allowed per injection: 2200 MBq Maximum cumulated dose allowed per examination: 4400 MBq Intravenous Use
• Sestamibi. reconstitution with sodium pertechnetate (99mTc)
Maximum dose allowed per injection: 1000 MBq Intravenous Use

Locations

Country	Name	City	State
United Kingdom	University College Hospital London NHS Foundation Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Advanced Accelerator Applications

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography)	The primary objective is to compare PET vs. SPET, with the primary outcome being the specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography).	Up to 2 days	No
Secondary	Evaluate any difference in the clinical interpretation of the Rubidium-82 PET and Tc-99m-MIBI SPET images.		Up to 2 days	No
Secondary	Evaluate any difference in "Percentage myocardium" that is hypoperfused, between Rubidium-82 PET and Tc-99m-MIBI SPET.		Up to 2 days	No
Secondary	Evaluate any difference in image quality, artefacts and interpretative confidence between Rubidium-82 PET and Tc-99m-MIBI SPET.		Up to 2 days	No
Secondary	Evaluate any adverse events or reactions, during Rubidum-82 or Tc-MIBI administration.		Up to 2 days	Yes