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

Advanced Accelerator Applications

Status and phase: Completed; Phase 3

Conditions: Coronary Artery Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01379677

2009-016645-25 (EudraCT Number)

2009Rb82UK

Details and patient eligibility

About

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).

Enrollment: 135 patients

Sex: All

Ages: 40+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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135 participants in 1 patient group

Single arm

Other group

Description:

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.

Treatment:

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

Drug: Rubidium-82