Study Assessing Hybrid SPECT-CT With Labeled Leukocytes for Diagnosis of Vascular Prosthesis Infections

Phase 3

• Conditions: Vascular Prosthesis Infection
• Interventions: Biological: 99mTc-Exametazime (HMPAO)-labeled leukocytes

• Registration Number: NCT02538133
• Lead Sponsor: University Hospital, Angers

Brief Summary

Vascular Prothesis Infection is a rare but an extremely serious complication. Diagnosis is often difficult (germs are found only in 50% of cases). Conventional imagery is often non-specific and difficult to interpret especially in early postoperative phase. Leukocytes isolated from the patient's blood are labeled with a radiopharmaceutical technetium 99mTc-HMPAO.

The aim of this study is to assess the overall diagnostic performance of scintigraphy (hybrid SPEC-CT) with labeled leucocytes in diagnosis of subdiaphragmatic vascular prothesis infection.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-30
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-28
• Study Start: 2015-09
• Study First Posted: 2015-09-02
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-07
• Primary Completion: 2020-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• patient of more than 18 years old
• Patient with a subdiaphragmatic vascular prosthesis
• Vascular prosthesis infection suspected with clinical (flow from the scare and/or local pain and/or erythema and/or persistent fever and/or bacteraemia) and/or biological (inflammatory syndrome : elevated C-reactive protein and/or erythrocyte sedimentation rate (ESR) and/or white blood cells increased) infection signs
• Patient willing to participate with a signed informed consent
• Patient covered by a healthcare insurance

Exclusion Criteria

• Pregnant women or of childbearing age without effective contraception
• Prosthesis limited to a bare stent.
• Patient who has been committed to an institution by legal or regulatory order
• Contraindications for labeled leukocytes scintigraphy realization :
• Restlessness, inability to keep still lie at least 1 hour
• Claustrophobia
• Poor compliance predictable or impaired general condition making it impossible to carry out the examination
• Refusal to participate in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
99mTc-Exametazime (HMPAO)-labeled leucocytes	99mTc-Exametazime (HMPAO)-labeled leukocytes	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients correctly classified by interpreting scintigraphy for the diagnosis of vascular prosthesis infection. The percentage of patients correctly classified is assessed comparing with the diagnostic established by the expert committee.	One year after inclusion when vascular prosthesis infection is suspected and hybrid SPEC-CT with labeled leukocytes has been performed.	A visual analysis of scintigraphy for diagnosing vascular prosthesis infection. Scintigraphy is considered positive if at least one abnormal localization is seen at vascular prosthesis and if intensity is increasing over time on 20-24h delayed images.

Trial Locations

Locations (3)

CHU; 🇫🇷 Angers, France

CH; 🇫🇷 Le Mans, France

CHRU; 🇫🇷 Strasbourg, France