Assessment of Radiolabeled rhAnnexin V-128 in Infective Endocarditis (AnnIE)
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|ClinicalTrials.gov Identifier: NCT02459613|
Recruitment Status : Unknown
Verified July 2016 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was: Recruiting
First Posted : June 2, 2015
Last Update Posted : July 14, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Endocarditis Thrombosis||Other: 99mTc-Annexin V-128 SPECT||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation de la rhAnnexine V-128 radiomarquée Dans le Diagnostic de l'Endocardite Infectieuse, du Thrombus Atrial et de Leurs Complications Emboliques associées|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
99mTc Annexin V-128 SPECT
Other: 99mTc-Annexin V-128 SPECT
- Diagnostic sensitivity in infective endocarditis and atrial thrombus [ Time Frame: up to 4 weeks ]
- Diagnostic value (sensitivity and specificity) in infective endocarditis [ Time Frame: up to 4 weeks ]
- Diagnostic sensitivity in atrial thrombus [ Time Frame: up to 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02459613
|Contact: Francois Rouzet, MD, PhDfirstname.lastname@example.org|
|Paris, France, 75018|
|Principal Investigator:||Dominique Le Guludec, MD, PhD||Assistance Publique - Hôpitaux de Paris|