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Trial record 59 of 95 for:    gadobenate dimeglumine

Cardiac MRI in Measuring the Impact of Anti-androgen Treatment on Cardiac Function in Patients With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02722525
Recruitment Status : Active, not recruiting
First Posted : March 30, 2016
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Pelontonia
Information provided by (Responsible Party):
Steven Clinton, Ohio State University Comprehensive Cancer Center

Brief Summary:
Learning about the impact of anti-androgen treatment has on cardiac function in patients with prostate cancer may help plan treatment and help patients live more comfortably. This pilot clinical trial will utilize cardiac magnetic resonance imaging (MRI) before a patient starts hormone therapy and after 4 to 7 months of hormone therapy. The objective is to measure the impact of hormone therapy (anti-androgen treatment) on cardiac function in patients with prostate cancer.

Condition or disease Intervention/treatment Phase
Cardiovascular Injury Prostate Carcinoma Procedure: Magnetic Resonance Imaging Behavioral: Exercise Intervention Radiation: Gadopentetate Dimeglumine Procedure: Perfusion Magnetic Resonance Imaging Procedure: Spectroscopy Other: Laboratory Biomarker Analysis Not Applicable

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the impact of a minimum of 4 months of full androgen deprivation therapy (ADT) on cardiac and skeletal muscle structure and performance using novel cardiovascular magnetic resonance (CMR) approach.

OUTLINE:

Study participants will undergo a treadmill stress CMR focused on cardiac muscle comprised of resting MRI over 10-15 minutes followed by treadmill exercise until peak stress. Patients then undergo MRI and gadopentetate dimeglumine (Gd-diethylenetriamine penta-acetic acid [DTPA]) perfusion imaging immediately after exercise and after a 6-8 minute recovery period. Within 24 hours of treadmill CMR exam, patients also undergo skeletal muscle phosphorus magnetic resonance spectroscopy (PMRS) while at rest, during, and in the recovery phase of resistive lower extremity exercise which patients complete over 30 seconds. Both procedures are performed before initiation of ADT treatment (baseline) and 4-7 months after initiation of ADT treatment.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Impact of Anti-androgen Treatment on Cardiac Function
Study Start Date : October 2014
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Diagnostic (cardiac MRI, skeletal muscle PMRS)
Patients undergo a treadmill stress CMR focused on cardiac muscle comprised of resting MRI over 10-15 minutes followed by treadmill exercise until peak stress. Patients then undergo MRI and gadopentetate dimeglumine perfusion imaging immediately after exercise and after a 6-8 minute recovery period. Within 24 hours of treadmill CMR exam, patients also undergo skeletal muscle PMRS while at rest, during, and in the recovery phase of resistive lower extremity exercise which patients complete over 30 seconds. Both procedures are performed before initiation of ADT treatment (baseline) and 4-7 months after initiation of ADT treatment.
Procedure: Magnetic Resonance Imaging
Undergo treadmill stress CMR
Other Names:
  • Magnetic Resonance Imaging Scan
  • MRI
  • MRI Scan
  • NMRI

Behavioral: Exercise Intervention
Complete treadmill exercise

Radiation: Gadopentetate Dimeglumine
Undergo gadopentetate dimeglumine perfusion MRI
Other Names:
  • Gadolinium DTPA
  • Gd-DTPA
  • Magnevist
  • SH L 451 A
  • ZK 93035

Procedure: Perfusion Magnetic Resonance Imaging
Undergo gadopentetate dimeglumine perfusion MRI
Other Name: PW-MRI

Behavioral: Exercise Intervention
Complete resistive lower extremity exercise

Procedure: Spectroscopy
Undergo skeletal muscle PMRS

Other: Laboratory Biomarker Analysis
Correlative studies




Primary Outcome Measures :
  1. Heart rate (bpm) [ Time Frame: Up to 7 months post ADT initiation ]
  2. Maximal rate of oxygen consumption [ Time Frame: Up to 7 months post ADT initiation ]
  3. Cardiac muscle mass [ Time Frame: Up to 7 months post ADT initiation ]
  4. Ventricular performance assessed by cardiac stress MRI [ Time Frame: Up to 7 months post ADT initiation ]
  5. Myocardial perfusion reserve assessed by cardiac stress MRI [ Time Frame: Up to 7 months post ADT initiation ]
  6. Skeletal muscle energetics assessed by PMRS [ Time Frame: Up to 7 months post ADT initiation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have biopsy proven carcinoma of the prostate
  • Be planning to begin a course of at least 4 months of ADT; the ADT is defined as: (a) surgical castration; (b) gonadotropin-releasing hormone (GNRH) antagonist alone; (c) GNRH antagonist with oral androgen receptor blockade, and (d) GNRH antagonist, oral androgen receptor blockade, and 5-alpha reductase inhibitors; we will not include men with only oral anti-androgen therapy such as 5-alpha reductase inhibitors alone or oral anti-androgens alone
  • Have an ECOG (Eastern Cooperative Oncology Group) performance status of 0-1
  • Have plasma total cholesterol < 200 mg/dL
  • Have plasma triglycerides < 200 mg/dL
  • Have BUN/Cr (Blood urea nitrogen and serum creatinine) without clinically significant abnormalities after review by the study physicians
  • Liver enzymes without clinically significant abnormalities after review by the study physicians
  • CBC (complete blood count) without clinically significant abnormalities after review by the study physicians
  • PT/PTT/INR (prothrombin time/partial thromboplastin time) without clinically significant abnormalities after review by the study physicians
  • Voluntarily agree to participate and sign an informed consent document

Exclusion Criteria:

  • Have an active malignancy other than prostate cancer that requires therapy
  • Not be undergoing evaluation and workup for active cardiovascular disease; men with treated and stable cardiovascular disease may participate
  • Have plasma total cholesterol > 200 mg/dL or plasma triglycerides > 200 mg/dL
  • Have a calculated glomerular filtration rate (GFR) =< 30 mL/min/1.73 m^2
  • Are not free of unstable angina, arrhythmia, or severe systemic disease that would make moderate intensity exercise participation unsafe
  • Have any contra-indications to magnetic resonance (MR) examination such as allergy to MRI contrast media (gadolinium-DTPA [gadopentetate dimeglumine]), metallic foreign objects within the body, orbital metal, cerebral aneurysm clip, pacemaker, defibrillator, neurostimulator, any other medical metallic implant, claustrophobia, inability to lie flat for 30 minutes, and weight exceeding 300 pounds; if an MR contraindication is discovered during scanning that was overlooked during the screening process, the procedure will be stopped immediately and the subject will be removed from the scanner
  • Are receiving any form of renal replacement therapy or have a calculated glomerular filtration rate (GFR) < 30 mL/min/1.75 m²; results of serum creatinine testing will be reviewed for calculation of glomerular filtration rate (GFR); patients without a serum creatinine level drawn within the prior 3 months will have this drawn upon enrollment
  • Have uncontrolled hypertension and resting blood pressure exceeding 140/80 mmHg
  • In addition, subjects with any contraindications to exercise testing according to American Heart Association guidelines will not be enrolled; nonetheless, the cardiovascular magnetic resonance (CMR) cardiologist supervising the research portion of the exam will also evaluate each subject for evidence of any contra-indications; the absolute contra-indications include acute myocardial infarction, high-risk unstable angina, uncontrolled cardiac arrhythmias, active endocarditis, symptomatic severe aortic stenosis, decompensated symptomatic heart failure, acute pulmonary embolus or pulmonary infarction, acute non-cardiac disorder that may be aggravated by exercise, acute myocarditis or pericarditis, physical disability that would preclude safe and adequate test performance, and inability to provide consent; the relative contra-indications include left main coronary stenosis, moderate stenotic valvular heart disease, electrolyte abnormalities, tachyarrhythmias or bradyarrhythmias, atrial fibrillation with uncontrolled ventricular rate, hypertrophic cardiomyopathy, and high-degree atrioventricular node block; subjects with uncontrolled hypertension and resting blood pressure exceeding 140/80 mmHg will be excluded

Information from the National Library of Medicine

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): NCT02722525


Locations
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United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Pelontonia
Investigators
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Principal Investigator: Steven Clinton, MD, PhD Ohio State University Comprehensive Cancer Center

Additional Information:
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Responsible Party: Steven Clinton, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02722525     History of Changes
Other Study ID Numbers: OSU-14186
NCI-2015-00029 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

Keywords provided by Steven Clinton, Ohio State University Comprehensive Cancer Center:
ADT
Prostate cancer

Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Androgen Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Hormone Antagonists