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

University Hospital, Angers

Status and phase: Unknown; Phase 3

Conditions: Vascular Prosthesis Infection

Treatments: Biological: 99mTc-Exametazime (HMPAO)-labeled leukocytes

Study type: Interventional

Funder types: Other

Identifiers

NCT02538133

49RC14_0072

2015-001342-28 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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80 participants in 1 patient group

99mTc-Exametazime (HMPAO)-labeled leucocytes

Experimental group

Treatment:

Biological: 99mTc-Exametazime (HMPAO)-labeled leukocytes