Early Detection of Cardiac Toxicity in Childhood Cancer Survivors
NCT ID: NCT03038997
Last Updated: 2018-12-04
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
TERMINATED
Total Enrollment
42 participants
Study Classification
OBSERVATIONAL
Study Start Date
2014-11-30
Study Completion Date
2018-03-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
To evaluate cardiac MRI and/or serum biomarkers for detecting cardiac cardiac toxicity in children who received anthracycline based chemotherapy (ABC).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Defining Late Onset Occult Asymptomatic Cardiotoxicity in Childhood Cancer Survivors Exposed to Anthracycline Therapy
NCT01671696
Cardiovascular Disease
COMPLETED
Cardiotoxicity Assessment Through Comprehensive Heart Imaging to Predict Heart Failure
NCT04262830
Cardiotoxicity
Pediatric Cancer
Heart Failure
RECRUITING
Cardiac Injury Due to Anthracycline in Paediatric Oncological Patients
NCT06898320
Heart Injuries
Anthracycline
RECRUITING
Magnetic Resonance Imaging:A Window to Anthracycline Toxicity
NCT03211520
Cardiac Complications
COMPLETED
Reproducibility and Accuracy of a Portable System for Early Detection of Cardiac Dysfunction in Childhood Cancer Survivors
NCT05138991
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
ACTIVE_NOT_RECRUITING
NA
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Heart Failure
Cardiotoxicity
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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
* 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
* 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
Minimum Eligible Age
8 Years
Maximum Eligible Age
25 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Niti Dham
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Niti Dham
MD
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Niti Dham, MD
Role: PRINCIPAL_INVESTIGATOR
Children's National Research Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Children's National Health System
Washington D.C., District of Columbia, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
5405
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Cardiotoxicity and Other Late Effects After Radiotherapy and Immuno-chemoTherapy in Non-Hodgkin lYmphoma
NCT07041827
COMPLETED
New Biomarkers in the Prediction of Chemotherapy-induced Cardiotoxicity.
NCT05992337
UNKNOWN
Cardiac Impairments Following Pediatric Cardiotoxic Anti-cancer Treatment
NCT05261256
ENROLLING_BY_INVITATION
Prediction of Delayed Toxic Cardiomyopathy in Children
NCT05781672
TERMINATED
NA
Optimising Screening for the Cardiotoxic Effects of Cancer Therapy
NCT06817044
COMPLETED
PROactive Evaluation of Function to Avoid CardioToxicity
NCT03862131
TERMINATED
PHASE2
Early Detection of Broken Hearts in Cancer Patients
NCT02086695
COMPLETED
Myocardial Stress Perfusion Computed Tomography in the Evaluation of Patients With Acute Chest Pain Using a Novel 3rd Generation Dual-source CT System
NCT02308475
TERMINATED
NA
Early Predictor of Herceptin Cardio Toxicity in Breast Cancer Patients
NCT02062983
SUSPENDED
Subclinical Cardio-toxicities Evaluation With Strain Rate Echocardiography After Chemotherapy and/or Mediastinal Radiotherapy in Patient With Lymphoma
NCT03480087
COMPLETED
Myocardial Perfusion and Fibrosis in Cancer Survivors
NCT03191461
COMPLETED
Early Detection of Imaging-derived Subclinical Cardiac Injuries
NCT03575650
RECRUITING
Early Detection of Cardiomyopathy by Speckle Echo, High Sensitive Troponin and Cardiac Ryanodine Receptors
NCT03381014
UNKNOWN
Early Detection of Cardiotoxicity From Systemic and Radiation Therapy in Breast Cancer Patients
NCT04790266
COMPLETED
PET/CT Quantitative Assessment of Myocardial Blood Flow Changes in Oncologic Patients Receiving Checkpoint Inhibitor Therapy
NCT04538950
COMPLETED
PHASE1/PHASE2
The Magnetic Resonance Imaging Evaluation of Doxorubicin Cardiotoxicity
NCT00530101
COMPLETED
PHASE1
Vascular Endothelial Inflammation and Dysfunction in Pediatric Long-term Cancer Survivors
NCT02032121
COMPLETED
NA
Role of Multi-modality Imaging in the Assessment of Chemotherapy Related Cardiac Dysfunction Among Cancer Patients
NCT06206395
NOT_YET_RECRUITING
Comparison of Cardiac Computed Tomography for the Detection of Coronary Artery Disease With Nuclear Stress Test
NCT00352937
COMPLETED
Monitoring Radiation Induced Cardiac Damage by Blood Markers
NCT02481778
COMPLETED
Ultra-high-resolution CT vs. Conventional Angiography for Detecting Coronary Heart Disease
NCT04272060
COMPLETED
NA
Anthracycline Induced Cardiotoxicity - Early Detection by Combination of Diastolic Strain and T2-mapping
NCT03940625
COMPLETED
NA
Cardiac Dysfunction in Childhood Cancer Survivors
NCT03790943
RECRUITING
The Role of the EKG in Anticancer Drug Development
NCT01462383
COMPLETED