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

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ClinicalTrials.gov Identifier: NCT02538133
Recruitment Status : Recruiting
First Posted : September 2, 2015
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Vascular Prosthesis Infection Biological: 99mTc-Exametazime (HMPAO)-labeled leukocytes Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Tomoscintigraphie Hybride Aux Leucocytes Marqués Dans le Diagnostic Des Infections de Prothèses Vasculaires.
Study Start Date : September 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs
Drug Information available for: Exametazime

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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02538133


Contacts
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Contact: HERVE RAKOTONIRINA, Dr +33(0)241353412 HeRakotonirina@chu-angers.fr

Locations
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France
CHU Recruiting
Angers, France, 49933
Contact: Hervé Rakotonirina         
Principal Investigator: Hervé Rakotonirina         
Sub-Investigator: Valérie Rabier         
Sub-Investigator: Jean Picquet         
CH Recruiting
Le Mans, France, 72037
Contact: Helene Loubiere         
Principal Investigator: Hélène Loubière         
Sub-Investigator: Hikombo Hitoto         
Sub-Investigator: Mammar Hachemi         
CHRU Recruiting
Strasbourg, France, 67091
Contact: Nabil Chakfe         
Principal Investigator: Nabil Chakfe         
Sub-Investigator: Daniel Christmann         
Sub-Investigator: Céline Heimburger         
Sub-Investigator: Cyrille Blondet         
Sub-Investigator: Yves Hansmann         
Sub-Investigator: Fabien Thaveau         
Sub-Investigator: Mathieu Roussin         
Sponsors and Collaborators
University Hospital, Angers
Investigators
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Principal Investigator: HERVE RAKOTONIRINA, Dr University hospital, Angers, FRANCE

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02538133     History of Changes
Other Study ID Numbers: 49RC14_0072
2015-001342-28 ( EudraCT Number )
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: August 2015

Keywords provided by University Hospital, Angers:
99mTc-Exametazime (HMPAO)-Labeled Leukocytes
suspected subdiaphragmatic vascular prosthesis infection
diagnosis

Additional relevant MeSH terms:
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Infection
Communicable Diseases