NCT02869126

Stress and Rest Myocardial Tomoscintigraphies Using Mono- or Double-isotope Protocol With a Semiconductor Camera

Study of the Concordance Between a Traditional Protocol of Stress and Rest Myocardial Tomoscintigraphy Using 99mTc-sestamibi and a Double Isotope Protocol Using Thallium-201 and 99mTc-sestamibi, With a Semiconductor Camera

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose is to demonstrate the concordance of diagnostic information obtained with: 1. a conventional examination with 2 distinct recordings on D.SPECT camera after 99mTc-sestamibi injections, the first post-stress and the second at rest, 2 to 3 hours later, and 2. a double isotope examination with a supplementary recording after injection of a little activity of thallium-201 at rest after the first recording and before the second injection of 99mTc-sestamibi for conventional recording at rest, in patients showing abnormalities of myocardial perfusion in stress myocardial tomoscintigraphy.

Detailed description

Myocardial perfusion tomoscintigraphy is very used for diagnosis and characterization of abnormalities of stress and rest myocardial perfusion. This examination can be performed with semiconductor gamma cameras that are more performant than conventional cameras regarding spatial resolution, detection sensitivity and energy resolution. The amelioration of energy resolution could allow the realization of simultaneous recordings of a dye injected at rest and another injected during stress (double isotope recording), while conventional examination needs 2 different recordings, stress and rest, separated from several hours. In this study patients undergo a conventional examination with D.SPECT camera with 2 recordings, the first after injection of a little activity of 99mTc-sestamibi at stress (≤ 100 MBq) and the second, 2 hours later, after injection at rest of a 3 time bigger activity of 99mTc-sestamibi (≤ 300 MBq). An activity of thallium-201(≤ 50 MBq) is injected at rest after the first recording of stress. 5 minutes later, a supplementary double isotope recording is realized with D.SPECT camera (99mTc-Sestamibi-stress / thallium201-rest). The demonstration of the hypothesis of this study could considerably diminish the duration of the examination (from 3 to 4 hours to less than 1 hour).

Conditions

• Myocardial Perfusion

Interventions

Type	Name	Description
PROCEDURE	Tomoscintigraphy with D.SPECT camera (SPECTRUM Dynamics®, Israel)	* During stress test, intravenous injection of 99mTc-Sestamibi (between 80 and 150 MBq according to weight) in patient * Stress conventional acquisition with D.SPECT camera 20 min after injection * 60 min after 99mTc-Sestamibi injection, rest injection of thallium-201 (50% activity of stress 99mTc-Sestamibi) * double isotope acquisition 5 min after thallium-201 injection * injection of 99mTc-Sestamibi at rest (activity 3 times higher), after 2 hours from first 99mTc-Sestamibi injection * rest conventional acquisition 20 min later
DRUG	99mTc-Sestamibi	First intravenous injection between 80 and 150 MBq according to patient weight and second injection with 3-time-higher activity, 2 hours after the first For tomoscintigraphy
DRUG	Thallium-201	Injection of thallium-201 (50% activity of first 99mTc-Sestamibi injection) For tomoscintigraphy

Timeline

• Start date: 2012-09-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2016-08-16
• Last updated: 2016-08-16

Locations

2 sites across 1 country: France