Status:
UNKNOWN
Heart/Mediastinal Ratio Study for Potential Equivalence of Heart/Mediastinal Ratios at One and Two Hours to the Traditional Heart/Mediastinal Ratio Obtained at Four Hours
Lead Sponsor:
Nuclear Medicine Consultants, Inc.
Conditions:
Neuroendocrine Tumor
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to determine if the measurement (with a standard nuclear camera) of radioactivity normally present in the nervous system of your heart at four hours after the injection of...
Eligibility Criteria
Inclusion
- NET patients who are potential candidates for I-131 MIBG therapy, and are having whole body I-123 MIBG scintigraphy as standard of care.
- Male or female patients ≥ 18 years of age.
- Written informed consent from patients obtained in accordance to local guidelines.
- History and physical exam indicating low likelihood, \< 10 %, of any significant cardiac disease.
- Echocardiogram within normal limits, including absence of valvular disease and normal LVEF.
- Serum BNP within normal limits. -
Exclusion
- Patients on drugs which interfere with MIBG uptake - tricyclic antidepressants, phenylpropanolamine, pseudephredine, phenylephrine, sympathomimetics, amphetamines, reserpine, thorazine and thiothixines, calcium channel blockers, cocaine, and long-acting beta blockers.
- \>10% likelihood of any significant heart disease, including myocardial ischemia, cardiomyopathies, uncontrolled hypertension, congestive heart failure and valvular heart disease, e.g. see "Likelihood of Assessment of Coronary Artery Disease" below.
- History of uncontrolled diabetes mellitus
- Signs/symptoms of neurological diseases (e.g., Parkinsonian syndromes) or other disease known to affect the sympathetic nervous system.
- Female patients who are pregnant or nursing (lactating), or adults of reproductive potential who are not using effective birth control methods. If there is any question of pregnancy, a serum bHCg will be collected.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01448083
Start Date
October 1 2011
Last Update
September 18 2012
Active Locations (1)
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1
Ochsner Medical Center - Kenner
Kenner, Louisiana, United States, 70065