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

NCT02869126 | Completed

• 1 other identifier: 2012-A00569-34
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose is to demonstrate the concordance of diagnostic information obtained with:

1. 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,
2. 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,

Conditions

Myocardial Perfusion

Keywords

99mTc-Sestamibi; thallium-201; semiconductor camera

Outcome Measures

Primary Outcomes (2)

• Quality of images obtained with double isotope tomoscintigraphy and conventional tomoscintigraphy

  Bad; medium; good; very good

  day 0

• Nature of observed abnormalities obtained with double isotope tomoscintigraphy and conventional tomoscintigraphy

  Without abnormalities or artefacts (normal); with rest reversible abnormalities (ischemia); with rest non reversible abnormalities (infarction)

  day 0

Study Arms (1)

Patients

EXPERIMENTAL

Patients with abnormalities of myocardial perfusion detected with stress tomoscintigraphy, undergo double isotope myocardial tomoscintigraphy using Thallium-201 and 99mTc-sestamibi and traditional myocardial tomoscintigraphy using 99mTc-sestamibi with a semiconductor camera

Procedure: Tomoscintigraphy with D.SPECT camera (SPECTRUM Dynamics®, Israel); Drug: 99mTc-Sestamibi; Drug: Thallium-201

Interventions

Tomoscintigraphy with D.SPECT camera (SPECTRUM Dynamics®, Israel) PROCEDURE

* 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

Patients

99mTc-Sestamibi DRUG

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

Patients

Thallium-201 DRUG

Injection of thallium-201 (50% activity of first 99mTc-Sestamibi injection) For tomoscintigraphy

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (2)

Service de Médecine Nucléaire - CLCC Jean Perrin

Clermont-Ferrand, France

Location

Service de Médecine Nucléaire - Hôpital de Brabois

Vandœuvre-lès-Nancy, France

Location

MeSH Terms

Interventions

Technetium Tc 99m Sestamibi; Thallium-201

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Organotechnetium Compounds; Organometallic Compounds

Study Officials

• Wassila DJABALLAH, Dr

  Service de Médecine Nucléaire, Hôpital de Brabois, 54511 Vandœuvre les Nancy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2016
• First Posted: August 16, 2016
• Study Start: September 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: August 16, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)