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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02538133

Acronym

LEUCOPRO

Enrollment

Registered

2015-09-02

Start date

2015-09-30

Completion date

2020-01-31

Last updated

2019-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Prosthesis Infection

Keywords

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

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.

Interventions

BIOLOGICAL99mTc-Exametazime (HMPAO)-labeled leukocytes

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.	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.

Countries

France

Contacts

Primary ContactHERVE RAKOTONIRINA, Dr

HeRakotonirina@chu-angers.fr+33(0)241353412

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026