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

This study is currently recruiting participants.

Verified April 2012 by Advanced Accelerator Applications

Sponsor:

Information provided by (Responsible Party):

Advanced Accelerator Applications

ClinicalTrials.gov Identifier:

NCT01379677

First received: June 9, 2011

Last updated: January 24, 2013

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 9, 2011

Last Updated Date

January 24, 2013

Start Date ^ICMJE

February 2011

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography) [ Time Frame: Up to 2 days ] [ Designated as safety issue: No ]

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).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01379677 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evaluate any difference in the clinical interpretation of the Rubidium-82 PET and Tc-99m-MIBI SPET images. [ Time Frame: Up to 2 days ] [ Designated as safety issue: No ]
Evaluate any difference in "Percentage myocardium" that is hypoperfused, between Rubidium-82 PET and Tc-99m-MIBI SPET. [ Time Frame: Up to 2 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Evaluate any adverse events or reactions, during Rubidum-82 or Tc-MIBI administration. [ Time Frame: Up to 2 days ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Evaluate any difference in the clinical interpretation of the Rubidium-82 PET and Tc-99m-MIBI SPET images. [ Time Frame: Up to 2 days ] [ Designated as safety issue: No ]
Evaluate any difference in "Percentage myocardium" that is hypoperfused, between Rubidium-82 PET and Tc-99m-MIBI SPET. [ Time Frame: Up to 2 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Evaluate patient satisfaction with and tolerance of Rubidium-82 PET and Tc-99m-MIBI SPET, assessed by a questionnaire, appreciating that the pharmacological stress test will be the same for both. [ Time Frame: Up to 2 days ] [ Designated as safety issue: No ]
Evaluate any adverse events or reactions, during Rubidum-82 or Tc-MIBI administration. [ Time Frame: Up to 2 days ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

Drug: Rubidium-82
Maximum dose allowed per injection: 2200 MBq Maximum cumulated dose allowed per examination: 4400 MBq Intravenous Use

Other Name: CardioGen-82
Drug: Sestamibi. reconstitution with sodium pertechnetate (99mTc)
Maximum dose allowed per injection: 1000 MBq Intravenous Use

Other Name: Technescan MIBI

Study Arm (s)

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.

Interventions:

Drug: Rubidium-82
Drug: Sestamibi. reconstitution with sodium pertechnetate (99mTc)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

135

Estimated Completion Date

April 2013

Primary Completion Date

December 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Leon Menezes, Dr.

08451555000 ext 70539

leon.menezes@uclh.nhs.uk

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT01379677

Other Study ID Numbers ^ICMJE

2009Rb82UK, 2009-016645-25

Has Data Monitoring Committee

Yes

Responsible Party

Advanced Accelerator Applications

Study Sponsor ^ICMJE

Advanced Accelerator Applications

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Leon Menezes, Dr.

University College Hospital London NHS Foundation Trust

Information Provided By

Advanced Accelerator Applications

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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