Clinical trial NCT02869126: Stress and Rest Myocardial Tomoscintigraphies Using Mono- or Double-isotope Protocol With a Semiconductor Camera
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Perfusion
Keywords: 99mTc-Sestamibi
thallium-201
semiconductor camera
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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).

Eligibility criteria: Inclusion Criteria:

* \> 18, without guardianship, signed informed consent
* Without contraindication for myocardial perfusion tomoscintigraphy and stress technique (dipyridamole and/or effort), according to common criteria to French Societies of Cardiology and Nuclear Medicine, as it is requested for all patients needing this routine examination
* Not in life-and-death emergency, with a stable clinical state (without cardiac insufficiency or instable coronary, without hypertension not well-stabilized under treatment)
* Effective contraceptive method for women of childbearing potential
* Weight ≤ 100 kg (\> 100 kg patients need higher injected activities in order to obtain adequate image quality)
* Perfusion abnormalities on stress images

Exclusion Criteria:

* \< 18
* Contraindications to stress test (effort and/or dipyridamole)
* Hypersensibility to thallium201 chloride or one of excipients
* Claustrophobic patient or incapable to stay lying down for 30 minutes
* Pregnancy or doubt of pregnancy
* Breastfeeding woman
* Weight \> 100 kg
* Non affiliation to social security plan

Primary outcomes:
measure: Quality of images obtained with double isotope tomoscintigraphy and conventional tomoscintigraphy
timeFrame: day 0
measure: Nature of observed abnormalities obtained with double isotope tomoscintigraphy and conventional tomoscintigraphy
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont Ferrand
country: France
facility: Service de Médecine Nucléaire - CLCC Jean Perrin
city: Vandœuvre les Nancy
country: France
facility: Service de Médecine Nucléaire - Hôpital de Brabois
Study officials:
affiliation: Service de Médecine Nucléaire, Hôpital de Brabois, 54511 Vandœuvre les Nancy
name: Wassila DJABALLAH, Dr
role: PRINCIPAL_INVESTIGATOR
References: