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

Primary Purpose

Vascular Prosthesis Infection

Status

Unknown status

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

99mTc-Exametazime (HMPAO)-labeled leukocytes

About this trial

This is an interventional diagnostic trial for Vascular Prosthesis Infection focused on measuring 99mTc-Exametazime (HMPAO)-Labeled Leukocytes, suspected subdiaphragmatic vascular prosthesis infection, diagnosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

CHURecruiting
CHRecruiting
CHRURecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

99mTc-Exametazime (HMPAO)-labeled leucocytes

Arm Description

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02538133

First Posted

July 30, 2015

Last Updated

March 6, 2019

Sponsor

University Hospital, Angers

1. Study Identification

Unique Protocol Identification Number

NCT02538133

Brief Title

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

Acronym

LEUCOPRO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

January 2020 (Anticipated)

Study Completion Date

January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Angers

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vascular Prosthesis Infection

Keywords

99mTc-Exametazime (HMPAO)-Labeled Leukocytes, suspected subdiaphragmatic vascular prosthesis infection, diagnosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

99mTc-Exametazime (HMPAO)-labeled leucocytes

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

99mTc-Exametazime (HMPAO)-labeled leukocytes

Intervention Description

Hybrid tomoscintigraphy with labeled leucocytes for patients with suspected vascular prosthesis infection

Primary Outcome Measure Information:

Title

Description

Time Frame

One year after inclusion when vascular prosthesis infection is suspected and hybrid SPEC-CT with labeled leukocytes has been performed.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

HERVE RAKOTONIRINA, Dr

Phone

+33(0)241353412

HeRakotonirina@chu-angers.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

HERVE RAKOTONIRINA, Dr

Organizational Affiliation

University hospital, Angers, FRANCE

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU

City

Angers

ZIP/Postal Code

49933

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hervé Rakotonirina

First Name & Middle Initial & Last Name & Degree

Hervé Rakotonirina

First Name & Middle Initial & Last Name & Degree

Valérie Rabier

First Name & Middle Initial & Last Name & Degree

Jean Picquet

Facility Name

City

Le Mans

ZIP/Postal Code

72037

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Helene Loubiere

First Name & Middle Initial & Last Name & Degree

Hélène Loubière

First Name & Middle Initial & Last Name & Degree

Hikombo Hitoto

First Name & Middle Initial & Last Name & Degree

Mammar Hachemi

Facility Name

CHRU

City

Strasbourg

ZIP/Postal Code

67091

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nabil Chakfe

First Name & Middle Initial & Last Name & Degree

Nabil Chakfe

First Name & Middle Initial & Last Name & Degree

Daniel Christmann

First Name & Middle Initial & Last Name & Degree

Céline Heimburger

First Name & Middle Initial & Last Name & Degree

Cyrille Blondet

First Name & Middle Initial & Last Name & Degree

Yves Hansmann

First Name & Middle Initial & Last Name & Degree

Fabien Thaveau

First Name & Middle Initial & Last Name & Degree

Mathieu Roussin

12. IPD Sharing Statement

Learn more about this trial

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

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