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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2020-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Vascular Prosthesis Infection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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99mTc-Exametazime (HMPAO)-labeled leucocytes

Group Type EXPERIMENTAL

99mTc-Exametazime (HMPAO)-labeled leukocytes

Intervention Type BIOLOGICAL

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

Interventions

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99mTc-Exametazime (HMPAO)-labeled leukocytes

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No