- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT03038997
Early Detection of Cardiac Toxicity in Childhood Cancer Survivors
30 novembre 2018 aggiornato da: Niti Dham
To evaluate cardiac MRI and/or serum biomarkers for detecting cardiac cardiac toxicity in children who received anthracycline based chemotherapy (ABC).
Panoramica dello studio
Stato
Terminato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Osservativo
Iscrizione (Effettivo)
42
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
District of Columbia
-
Washington, District of Columbia, Stati Uniti, 20010
- Children's National Health System
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 8 anni a 25 anni (Bambino, Adulto)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Patients with previous exposure to anthracyclines between the ages of 8-25 years of age.
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Echocardiogram marker measurements pre ABC chemo and post ABC
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Detection of cardiac toxicity on MRI and echocardiogram
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Investigatore principale: Niti Dham, MD, Children's National
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 novembre 2014
Completamento primario (Effettivo)
11 marzo 2018
Completamento dello studio (Effettivo)
11 marzo 2018
Date di iscrizione allo studio
Primo inviato
30 gennaio 2017
Primo inviato che soddisfa i criteri di controllo qualità
30 gennaio 2017
Primo Inserito (Stima)
1 febbraio 2017
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
4 dicembre 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
30 novembre 2018
Ultimo verificato
1 novembre 2018
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 5405 (OHSU Knight Cancer Institute)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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