Assessment of Radiolabeled rhAnnexin V-128 in Infective Endocarditis

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

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-05

Study Completion Date

2017-05-31

Brief Summary

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Intraluminal thrombi adherent to cardiac valves or atria share a common pathophysiology involving the aggregation of activated platelets with phosphatidylserine (PS) expression on the outer layer of the thrombus. They also share common complications, i.e. damages to the underlying myocardium and embolic risk related to thrombus fragmentation. The diagnostic work-up, currently relying on morphologic imaging alone (mainly echography), lacks sensitivity and does not allow to differentiate between active (renewal and growth activity) and quiescent (scarred) thrombus. It is therefore highly desirable to develop a new approach able to non-invasively provide insight on the biological activity of thrombi and to detect embolic events in a single exam.

Annexin V is a 36 kDa endogenous glycoprotein which binds PS with nanomolar affinity. Radiolabeled Annexin V has been shown to provide molecular imaging of PS expressed by apoptotic cells or activated platelets. The ability of the imaging agent to bind mural thrombus has been established in vivo in a murine model of abdominal aortic aneurysm and ex vivo in human. It has been also shown that radiolabeled Annexin V allowed in vivo detection of vegetations and secondary pulmonary emboli with high sensitivity in various animal models of infective endocarditis.

A radiolabeling kit of annexin V complying with GMP requirements has been developed (rhAnnexine V-128, Advanced Accelerator Applications - Atreus) and is currently available. AnniE is a single centre, proof of concept, interventional, open, non-randomized study aiming at evaluating the sensitivity of 99mTc-Annexin V-128 in the detection thrombus in comparison with reference imaging in patients presenting with either: 1/ infective endocarditis or 2/ atrial thrombus. The safety of the 99mTc-Annexin V-128 will be assessed in a first phase (10 first patients enrolled). Data in relation with safety of the imaging agent will be reviewed by an independent Data and Safety Monitoring Board (DSMB); in case of positive answer, the study will continue with a second phase. The data gathered in all patients (n=120) will be used to determine outcome measures.

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Detailed Description

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Conditions

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Endocarditis Thrombosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Imaging

99mTc Annexin V-128 SPECT

Group Type EXPERIMENTAL

99mTc-Annexin V-128 SPECT

Intervention Type DRUG

Interventions

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99mTc-Annexin V-128 SPECT

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* stable clinical status
* signed informed consent
* contraception in women of childhood potential

* Endocarditis group:
* definite ou possible endocarditis (modified Duke criteria)

* Atrial thrombosis group:
* presence of atrial thrombosis evidenced by transesophageal echocardiography

Exclusion Criteria

* pregnant or lactating women
* contra-indication to both MRI and CT

* Endocarditis group:
* history of cardiac surgery in relation with the current episode
* (effective) antibiotic regimen for more than 15 days

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No