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

March 6, 2019 updated by: University Hospital, Angers

Tomoscintigraphie Hybride Aux Leucocytes Marqués Dans le Diagnostic Des Infections de Prothèses Vasculaires.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Recruiting
        • CHU
        • Sub-Investigator:
          • Valérie Rabier
        • Contact:
          • Hervé Rakotonirina
        • Principal Investigator:
          • Hervé Rakotonirina
        • Sub-Investigator:
          • Jean Picquet
      • Le Mans, France, 72037
        • Recruiting
        • CH
        • Contact:
          • Helene Loubiere
        • Principal Investigator:
          • Hélène Loubière
        • Sub-Investigator:
          • Hikombo Hitoto
        • Sub-Investigator:
          • Mammar Hachemi
      • Strasbourg, France, 67091
        • Recruiting
        • CHRU
        • Contact:
          • Nabil Chakfe
        • Principal Investigator:
          • Nabil Chakfe
        • Sub-Investigator:
          • Daniel Christmann
        • Sub-Investigator:
          • Céline Heimburger
        • Sub-Investigator:
          • Cyrille Blondet
        • Sub-Investigator:
          • Mathieu Roussin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 99mTc-Exametazime (HMPAO)-labeled leucocytes
Biological: 99mTc-Exametazime (HMPAO)-labeled leukocytes
Hybrid tomoscintigraphy with labeled leucocytes for patients with suspected vascular prosthesis infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
One year after inclusion when vascular prosthesis infection is suspected and hybrid SPEC-CT with labeled leukocytes has been performed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Principal Investigator: HERVE RAKOTONIRINA, Dr, University hospital, Angers, FRANCE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

July 30, 2015

First Submitted That Met QC Criteria

August 28, 2015

First Posted (Estimate)

September 2, 2015

Study Record Updates

Last Update Posted (Actual)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 6, 2019

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49RC14_0072
  • 2015-001342-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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