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

• Sponsor: University Hospital, Angers (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02538133
• Collaborator: (none)
• Enrollment: 80
• Locations: 3
• Arm: 1
• Duration (Months): 52
• Patients Per Site: 26.7
• Patients Per Site Per Month: 0.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vascular Prosthesis Infection	Biological: 99mTc-Exametazime (HMPAO)-labeled leukocytes	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Diagnostic
• Official Title: Tomoscintigraphie Hybride Aux Leucocytes Marqués Dans le Diagnostic Des Infections de Prothèses Vasculaires.
• Study Start Date: Sep 1, 2015
• Anticipated Primary Completion Date: Jan 1, 2020
• Anticipated Study Completion Date: Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 99mTc-Exametazime (HMPAO)-labeled leucocytes	Biological: 99mTc-Exametazime (HMPAO)-labeled leukocytes; Hybrid tomoscintigraphy with labeled leucocytes for patients with suspected vascular prosthesis infection

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU	Angers		France	49933
2	CH	Le Mans		France	72037
3	CHRU	Strasbourg		France	67091

Sponsors and Collaborators

• University Hospital, Angers

Investigators

• Principal Investigator: HERVE RAKOTONIRINA, Dr, University hospital, Angers, FRANCE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Angers
• ClinicalTrials.gov Identifier: NCT02538133
• Other Study ID Numbers: 49RC14_0072; 2015-001342-28
• First Posted: Sep 2, 2015
• Last Update Posted: Mar 7, 2019
• Last Verified: Aug 1, 2015

• Keywords provided by University Hospital, Angers: 99mTc-Exametazime (HMPAO)-Labeled Leukocytes; suspected subdiaphragmatic vascular prosthesis infection; diagnosis
• Additional relevant MeSH terms: Infections; Communicable Diseases

Study Results

No Results Posted as of Mar 7, 2019