- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03038997
Early Detection of Cardiac Toxicity in Childhood Cancer Survivors
30 novembre 2018 mis à jour par: Niti Dham
To evaluate cardiac MRI and/or serum biomarkers for detecting cardiac cardiac toxicity in children who received anthracycline based chemotherapy (ABC).
Aperçu de l'étude
Statut
Résilié
Les conditions
Description détaillée
Cardiac toxicity is a significant potential complication for patients receiving anthracycline chemotherapy.
Cells in the cardiovascular system have limited regenerative capability, making them susceptible to long term adverse effects from these chemotherapeutic agents.
The ability to detect subclinical changes in cardiac function will allow clinicians to use proven treatments to prevent further progression in this vulnerable population.
The current standard testing uses echocardiography, which is not as sensitive as cardiac MRI or serum biomarkers.
Type d'étude
Observationnel
Inscription (Réel)
42
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
District of Columbia
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Washington, District of Columbia, États-Unis, 20010
- Children's National Health System
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
8 ans à 25 ans (Enfant, Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Patients with previous exposure to anthracyclines between the ages of 8-25 years of age.
La description
Inclusion Criteria:
- Subjects that have received anthracycline based chemotherapy
- Age: 8 years old - 25 years old
- Subjects that do not require sedation for cardiac MRI.
- Subjects must have completed treatment in the last 10 years
Exclusion Criteria:
- Patients with significant congenital heart defects
- Patients with renal injury or renal failure, defined as an estimated glomerular filtration rate [eGFR] <30 ml/min/1.73 m2 body surface area), as previously calculated)
- Patients that require sedation for a cardiac MRI
- Subjects that are pregnant or lactating
- Patients with contraindications to a cardiac MRI:
- Cardiac pacemaker or implantable defibrillator
- Cerebral aneurysm clip
- Neural stimulator
- Metallic ocular foreign body
- Any implanted device (i.e. insulin pump, drug infusion device)
- Claustrophobia
- Metal shrapnel or bullet
- Investigator assessment of inability to comply with protocol
- Unable/unwilling to lie still throughout the research procedure
- Persons with cognitive impairment
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Echocardiogram marker measurements pre ABC chemo and post ABC
Délai: At the end of each cardiac MRI exam through study completion, up to 5 years
|
•Measure echocardiogram markers on pre anthracycline based chemotherapy (ABC) and post ABC echocardiograms, using standard echocardiogram measurements and speckle tracking.
|
At the end of each cardiac MRI exam through study completion, up to 5 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Detection of cardiac toxicity on MRI and echocardiogram
Délai: At the end of each cardiac MRI exam through study completion, up to 5 years
|
•Measure sensitivity of detecting cardiac toxicity between standard echocardiogram, speckle tracking on echo, and MRI
|
At the end of each cardiac MRI exam through study completion, up to 5 years
|
Serum biomarkers correlation
Délai: At the end of the study, up to 10 years
|
•Correlate measurement of serum biomarkers with prevalence of cardiac changes measured on echocardiograms and MRI imaging.
|
At the end of the study, up to 10 years
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Niti Dham, MD, Children's National
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Deo A, Fogel M, Cowper SE. Nephrogenic systemic fibrosis: a population study examining the relationship of disease development to gadolinium exposure. Clin J Am Soc Nephrol. 2007 Mar;2(2):264-7. doi: 10.2215/CJN.03921106. Epub 2007 Feb 7.
- Sawaya H, Sebag IA, Plana JC, Januzzi JL, Ky B, Tan TC, Cohen V, Banchs J, Carver JR, Wiegers SE, Martin RP, Picard MH, Gerszten RE, Halpern EF, Passeri J, Kuter I, Scherrer-Crosbie M. Assessment of echocardiography and biomarkers for the extended prediction of cardiotoxicity in patients treated with anthracyclines, taxanes, and trastuzumab. Circ Cardiovasc Imaging. 2012 Sep 1;5(5):596-603. doi: 10.1161/CIRCIMAGING.112.973321. Epub 2012 Jun 28.
- Lipshultz SE, Adams MJ, Colan SD, Constine LS, Herman EH, Hsu DT, Hudson MM, Kremer LC, Landy DC, Miller TL, Oeffinger KC, Rosenthal DN, Sable CA, Sallan SE, Singh GK, Steinberger J, Cochran TR, Wilkinson JD; American Heart Association Congenital Heart Defects Committee of the Council on Cardiovascular Disease in the Young, Council on Basic Cardiovascular Sciences, Council on Cardiovascular and Stroke Nursing, Council on Cardiovascular Radiolo. Long-term cardiovascular toxicity in children, adolescents, and young adults who receive cancer therapy: pathophysiology, course, monitoring, management, prevention, and research directions: a scientific statement from the American Heart Association. Circulation. 2013 Oct 22;128(17):1927-95. doi: 10.1161/CIR.0b013e3182a88099. Epub 2013 Sep 30. No abstract available. Erratum In: Circulation. 2013 Nov 5;128(19):e394.
- Wassmuth R, Lentzsch S, Erdbruegger U, Schulz-Menger J, Doerken B, Dietz R, Friedrich MG. Subclinical cardiotoxic effects of anthracyclines as assessed by magnetic resonance imaging-a pilot study. Am Heart J. 2001 Jun;141(6):1007-13. doi: 10.1067/mhj.2001.115436.
- Mahrholdt H, Wagner A, Judd RM, Sechtem U, Kim RJ. Delayed enhancement cardiovascular magnetic resonance assessment of non-ischaemic cardiomyopathies. Eur Heart J. 2005 Aug;26(15):1461-74. doi: 10.1093/eurheartj/ehi258. Epub 2005 Apr 14.
- Lai WW, Geva T, Shirali GS, Frommelt PC, Humes RA, Brook MM, Pignatelli RH, Rychik J; Task Force of the Pediatric Council of the American Society of Echocardiography; Pediatric Council of the American Society of Echocardiography. Guidelines and standards for performance of a pediatric echocardiogram: a report from the Task Force of the Pediatric Council of the American Society of Echocardiography. J Am Soc Echocardiogr. 2006 Dec;19(12):1413-30. doi: 10.1016/j.echo.2006.09.001. No abstract available.
- Schwartz RG, Jain D, Storozynsky E. Traditional and novel methods to assess and prevent chemotherapy-related cardiac dysfunction noninvasively. J Nucl Cardiol. 2013 Jun;20(3):443-64. doi: 10.1007/s12350-013-9707-1.
- Kremer LC, van Dalen EC, Offringa M, Voute PA. Frequency and risk factors of anthracycline-induced clinical heart failure in children: a systematic review. Ann Oncol. 2002 Apr;13(4):503-12. doi: 10.1093/annonc/mdf118.
- Kremer LC, van der Pal HJ, Offringa M, van Dalen EC, Voute PA. Frequency and risk factors of subclinical cardiotoxicity after anthracycline therapy in children: a systematic review. Ann Oncol. 2002 Jun;13(6):819-29. doi: 10.1093/annonc/mdf167.
- Shankar SM, Marina N, Hudson MM, Hodgson DC, Adams MJ, Landier W, Bhatia S, Meeske K, Chen MH, Kinahan KE, Steinberger J, Rosenthal D; Cardiovascular Disease Task Force of the Children's Oncology Group. Monitoring for cardiovascular disease in survivors of childhood cancer: report from the Cardiovascular Disease Task Force of the Children's Oncology Group. Pediatrics. 2008 Feb;121(2):e387-96. doi: 10.1542/peds.2007-0575. Epub 2008 Jan 10.
- Steinherz LJ, Graham T, Hurwitz R, Sondheimer HM, Schwartz RG, Shaffer EM, Sandor G, Benson L, Williams R. Guidelines for cardiac monitoring of children during and after anthracycline therapy: report of the Cardiology Committee of the Childrens Cancer Study Group. Pediatrics. 1992 May;89(5 Pt 1):942-9.
- Cheung YF, Hong WJ, Chan GC, Wong SJ, Ha SY. Left ventricular myocardial deformation and mechanical dyssynchrony in children with normal ventricular shortening fraction after anthracycline therapy. Heart. 2010 Jul;96(14):1137-41. doi: 10.1136/hrt.2010.194118. Epub 2010 May 29.
- Mavinkurve-Groothuis AM, Marcus KA, Pourier M, Loonen J, Feuth T, Hoogerbrugge PM, de Korte CL, Kapusta L. Myocardial 2D strain echocardiography and cardiac biomarkers in children during and shortly after anthracycline therapy for acute lymphoblastic leukaemia (ALL): a prospective study. Eur Heart J Cardiovasc Imaging. 2013 Jun;14(6):562-9. doi: 10.1093/ehjci/jes217. Epub 2012 Oct 29.
- Lunning MA, Kutty S, Rome ET, Li L, Padiyath A, Loberiza F, Bociek RG, Bierman PJ, Vose JM, Armitage JO, Porter TR. Cardiac magnetic resonance imaging for the assessment of the myocardium after doxorubicin-based chemotherapy. Am J Clin Oncol. 2015 Aug;38(4):377-81. doi: 10.1097/COC.0b013e31829e19be.
- Weidemann F, Jamal F, Sutherland GR, Claus P, Kowalski M, Hatle L, De Scheerder I, Bijnens B, Rademakers FE. Myocardial function defined by strain rate and strain during alterations in inotropic states and heart rate. Am J Physiol Heart Circ Physiol. 2002 Aug;283(2):H792-9. doi: 10.1152/ajpheart.00025.2002.
- Pirat B, McCulloch ML, Zoghbi WA. Evaluation of global and regional right ventricular systolic function in patients with pulmonary hypertension using a novel speckle tracking method. Am J Cardiol. 2006 Sep 1;98(5):699-704. doi: 10.1016/j.amjcard.2006.03.056. Epub 2006 Jul 17.
- Dogru A, Cabuk D, Sahin T, Dolasik I, Temiz S, Uygun K. Evaluation of cardiotoxicity via speckle-tracking echocardiography in patients treated with anthracyclines. Onkologie. 2013;36(12):712-6. doi: 10.1159/000356850. Epub 2013 Nov 20.
- Oberholzer K, Kunz RP, Dittrich M, Thelen M. [Anthracycline-induced cardiotoxicity: cardiac MRI after treatment for childhood cancer]. Rofo. 2004 Sep;176(9):1245-50. doi: 10.1055/s-2004-813416. German.
- Kellman P, Wilson JR, Xue H, Bandettini WP, Shanbhag SM, Druey KM, Ugander M, Arai AE. Extracellular volume fraction mapping in the myocardium, part 2: initial clinical experience. J Cardiovasc Magn Reson. 2012 Sep 11;14(1):64. doi: 10.1186/1532-429X-14-64.
- Florian A, Ludwig A, Rosch S, Yildiz H, Sechtem U, Yilmaz A. Myocardial fibrosis imaging based on T1-mapping and extracellular volume fraction (ECV) measurement in muscular dystrophy patients: diagnostic value compared with conventional late gadolinium enhancement (LGE) imaging. Eur Heart J Cardiovasc Imaging. 2014 Sep;15(9):1004-12. doi: 10.1093/ehjci/jeu050. Epub 2014 Mar 30.
- Menon SC, Etheridge SP, Liesemer KN, Williams RV, Bardsley T, Heywood MC, Puchalski MD. Predictive value of myocardial delayed enhancement in Duchenne muscular dystrophy. Pediatr Cardiol. 2014 Oct;35(7):1279-85. doi: 10.1007/s00246-014-0929-z. Epub 2014 May 15.
- Yildirim A, Tunaoglu FS, Kambur K, Pinarli FG. The utility of NT-proBNP and various echocardiographic methods in the determination of doxorubicin induced subclinical late cardiotoxicity. Kardiol Pol. 2013;71(1):40-6.
- Colombo A, Cardinale D. Using cardiac biomarkers and treating cardiotoxicity in cancer. Future Cardiol. 2013 Jan;9(1):105-18. doi: 10.2217/fca.12.73.
- Ky B, Putt M, Sawaya H, French B, Januzzi JL Jr, Sebag IA, Plana JC, Cohen V, Banchs J, Carver JR, Wiegers SE, Martin RP, Picard MH, Gerszten RE, Halpern EF, Passeri J, Kuter I, Scherrer-Crosbie M. Early increases in multiple biomarkers predict subsequent cardiotoxicity in patients with breast cancer treated with doxorubicin, taxanes, and trastuzumab. J Am Coll Cardiol. 2014 Mar 4;63(8):809-16. doi: 10.1016/j.jacc.2013.10.061. Epub 2013 Nov 27. Erratum In: J Am Coll Cardiol. 2016 Mar 22;67(11):1385.
- Ugander M, Oki AJ, Hsu LY, Kellman P, Greiser A, Aletras AH, Sibley CT, Chen MY, Bandettini WP, Arai AE. Extracellular volume imaging by magnetic resonance imaging provides insights into overt and sub-clinical myocardial pathology. Eur Heart J. 2012 May;33(10):1268-78. doi: 10.1093/eurheartj/ehr481. Epub 2012 Jan 24.
- Cao Y, Huang DQ, Shih G, Prince MR. Signal Change in the Dentate Nucleus on T1-Weighted MR Images After Multiple Administrations of Gadopentetate Dimeglumine Versus Gadobutrol. AJR Am J Roentgenol. 2016 Feb;206(2):414-9. doi: 10.2214/AJR.15.15327. Epub 2015 Dec 23.
- Jost G, Lenhard DC, Sieber MA, Lohrke J, Frenzel T, Pietsch H. Signal Increase on Unenhanced T1-Weighted Images in the Rat Brain After Repeated, Extended Doses of Gadolinium-Based Contrast Agents: Comparison of Linear and Macrocyclic Agents. Invest Radiol. 2016 Feb;51(2):83-9. doi: 10.1097/RLI.0000000000000242.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 novembre 2014
Achèvement primaire (Réel)
11 mars 2018
Achèvement de l'étude (Réel)
11 mars 2018
Dates d'inscription aux études
Première soumission
30 janvier 2017
Première soumission répondant aux critères de contrôle qualité
30 janvier 2017
Première publication (Estimation)
1 février 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 décembre 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 novembre 2018
Dernière vérification
1 novembre 2018
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 5405 (OHSU Knight Cancer Institute)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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