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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01379677

Enrollment

135

Registered

2011-06-23

Start date

2011-02-28

Completion date

2013-11-30

Last updated

2014-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease, Myocardial perfusion imaging, Rubidium, Technetium

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).

Interventions

DRUGRubidium-82

Maximum dose allowed per injection: 2200 MBq Maximum cumulated dose allowed per examination: 4400 MBq Intravenous Use

DRUGSestamibi. reconstitution with sodium pertechnetate (99mTc)

Maximum dose allowed per injection: 1000 MBq Intravenous Use

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026