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

May 13, 2014 updated by: Advanced Accelerator Applications

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, NW1 2BU
        • University College Hospital London NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single arm
This is an Head to Head Comparison between Rubidium-82 PET and Tc-99m-MIBI SPET with CTA as gold standard. All the patients will undergo the three imaging protocols.
Drug: Rubidium-82
Maximum dose allowed per injection: 2200 MBq Maximum cumulated dose allowed per examination: 4400 MBq Intravenous Use
Other Names:
  • CardioGen-82
Drug: Sestamibi. reconstitution with sodium pertechnetate (99mTc)
Maximum dose allowed per injection: 1000 MBq Intravenous Use
Other Names:
  • Technescan MIBI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography)
Time Frame: Up to 2 days
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

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate any difference in the clinical interpretation of the Rubidium-82 PET and Tc-99m-MIBI SPET images.
Time Frame: Up to 2 days
Up to 2 days
Evaluate any difference in "Percentage myocardium" that is hypoperfused, between Rubidium-82 PET and Tc-99m-MIBI SPET.
Time Frame: Up to 2 days
Up to 2 days
Evaluate any difference in image quality, artefacts and interpretative confidence between Rubidium-82 PET and Tc-99m-MIBI SPET.
Time Frame: Up to 2 days
Up to 2 days
Evaluate any adverse events or reactions, during Rubidum-82 or Tc-MIBI administration.
Time Frame: Up to 2 days
Up to 2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Advanced Accelerator Applications

Investigators

  • Principal Investigator: Leon Menezes, Dr., University College Hospital London NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

June 9, 2011

First Submitted That Met QC Criteria

June 22, 2011

First Posted (Estimate)

June 23, 2011

Study Record Updates

Last Update Posted (Estimate)

May 14, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009Rb82UK
  • 2009-016645-25 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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