A Phase 3 interventional study of 99mTc-Exametazime (HMPAO)-labeled leukocytes in Vascular Prosthesis Infection, sponsored by University Hospital, Angers. Status unknown at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-07.
Sponsored by University Hospital, Angers · Phase 3, Interventional, and Diagnostic
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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This study's planned enrollment of 80 is close to the median of 80 across 762 interventional studies indexed under Disease.
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Exclusion Criteria:
Biological: 99mTc-Exametazime (HMPAO)-labeled leukocytes
Hybrid tomoscintigraphy with labeled leucocytes for patients with suspected vascular prosthesis infection
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.
Time frame: One year after inclusion when vascular prosthesis infection is suspected and hybrid SPEC-CT with labeled leukocytes has been performed.
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