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

Phase 3

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Rubidium-82; Drug: Sestamibi. reconstitution with sodium pertechnetate (99mTc)

• Registration Number: NCT01379677
• Lead Sponsor: Advanced Accelerator Applications

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 available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-06-22
• Study First Posted: 2011-06-23
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-13
• Last Update Posted: 2014-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	Rubidium-82	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.
Single arm	Sestamibi. reconstitution with sodium pertechnetate (99mTc)	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.

Primary Outcome Measures

Name	Time	Method
The specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography)	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).

Secondary Outcome Measures

Name	Time	Method
Evaluate any adverse events or reactions, during Rubidum-82 or Tc-MIBI administration.	Up to 2 days
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

Trial Locations

Locations (1)

University College Hospital London NHS Foundation Trust; 🇬🇧 London, United Kingdom