ASPER: Early Detection of Broken Hearts in Cancer Patients
Study Details
Study Description
Brief Summary
The early detection of BVZ or Sunitinib mediated cardiotoxicity using cardiac biomarkers and novel Transthoracic Echocardiogram (TTE) techniques may allow one to adjust treatment and/or administer prophylactic cardioprotective agents, prior to the development of irreversible cardiac dysfunction. We hypothesize that cardiac biomarkers, TVI/strain-derived indices will be able to accurately detect subtle cardiac injury at a time when conventional Left Ventricular Ejection Fraction (LVEF) remains normal in BVZ or Sunitinib mediated cardiotoxicity. Additionally, we hypothesize that Endothelial Function Test (EndoPAT) testing can detect early BVZ or Sunitinib mediated endothelial dysfunction.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
A total of 100 individuals (50 receiving BVZ and 50 receiving Sunitinib) will be prospectively enrolled . (80 at Mayo Clinic [80 receiving BVZ, Sunitinib ,or Pazopanib] and 20 at St. Boniface General Hospital (SBGH)). Patients receiving either BVZ 5mg/kg iv ,Sunitinib 50 mg po daily, or Pazopanib for advanced Metastatic carcinoma will be screened for potential eligibility in the study. For metastatic renal cancer treatments, Sunitinib doses are (oral) 50 mg once a day for 4 weeks followed by a two week off period. The six week cycle is then repeated. In case of toxicities observed with the dose, a 25% reduction in the daily dose during the "on" period is performed (37.5 mg). Patients will be studied at 7 time points: i) Baseline; ii) Day 1; iii) Day 5; iv) 4-6 weeks ; v) 3 months; vi) 6 months after the initiation of both drugs (BVZ and Sunitinib) ; and vii) 12 months after the initiation of BVZ drug only (Figure 1). Three visits (baseline, 4-6 weeks , and 3 months) are considered part of standard clinical care, and four visits are for research. At each visit, in addition to standard of care provided by the Oncologist, blood will be drawn to measure high sensitivity troponin-T (hsTnT) and Natriuretic-proBNP. The patients will also undergo a TTE with tissue velocity imaging (TVI), strain and left ventricular opacification (LVO) and myocardial perfusion at each time point. EndoPAT test will also be performed at baseline, and 3 months. The baseline, 4-6 weeks, and 3 month visits will be part of your standard clinical care and followup.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cancer Group All subjects with cancer who will be treated with anyone of the following chemotherapy drugs; Pazopanib, Sutent or Bevacizumab |
Outcome Measures
Primary Outcome Measures
- Number of participants with changes in Tissue velocity imaging (TVI), myocardial deformation indices (Strain, strain rate, twist and torsion), and diastolic function indices (Mitral Valve Pulsed Wave Doppler, Tissue Doppler Imaging, Left Atrial volumes) [Baseline to 2 years]
Secondary Outcome Measures
- Number of participants with changes in quantitative myocardial perfusion parameters including myocardial blood flow velocity and myocardial blood flow derived from contrast perfusion echocardiography [Baseline to 2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with advanced cancer
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Treatment plan includes BVZ ,Sunitinib, or Pazopanib
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Ages 18 - 90 years old -
Exclusion Criteria: Left Ventricular EF < 50%
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Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 2 | St. Boniface General Hospital | Winnipeg | Manitoba | Canada | R2H 2A6 |
Sponsors and Collaborators
- Mayo Clinic
- The Asper Foundation
- St. Boniface Hospital
- Lantheus Medical Imaging
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 12-005362