Development of a PET-MR Myocardial Perfusion Examination Using Regadenoson
Palabras clave
Abstracto
Descripción
Simultaneous acquisition PET-MRI is a new technology that has the potential to significantly impact diagnostic patient care. It combines high signal resolution MRI anatomic imaging and PET biological measurements, with the added benefit of radiation dose reduction in comparison to PET-CT. As the incidence of false positive SPECT-MPI studies secondary to attenuation artifact is relatively high and MRI coverage of the left ventricular myocardium is limited, it is likely that one of the immediate applications of PET-MRI technology is myocardial ischemia assessment.
PET has long been considered the noninvasive reference standard for myocardial perfusion. However, delayed contrast enhanced (DCE) MRI is very sensitive for infarct detection. Indeed, both PET and MR imaging have the potential to provide comprehensive whole heart ischemia and infarct detection.
PET-MR technology, with its ability to obtain simultaneous perfusion information via both PET and MRI, has the potential to obtain multiple, possibly redundant, data sets. On the other hand, it also has the potential to combine the best of both techniques to provide a highly robust examination that is both shorter and of lower radiation dose than the standard myocardial PET perfusion examination. Optimization of a protocol is necessary to develop a comprehensive protocol without redundancy. Because of its single injection capability, regadenoson is ideally suited to a protocol that will assess and employ dual-modality myocardial perfusion data collection.
It is expected that the best candidates for PET-MR myocardial perfusion imaging will likely be a) patients whose body habitus suggests that their SPECT-MPI examination would be limited by attenuation artifact -- women with large breasts and patients (usually men) with abdominal obesity and/or b) patients who may have a smaller region of ischemia that might be missed on an MRI examinations with limited perfusion coverage.
fechas
| Verificado por última vez: | 04/30/2018 |
| Primero enviado: | 01/22/2013 |
| Inscripción estimada enviada: | 01/26/2013 |
| Publicado por primera vez: | 01/29/2013 |
| Última actualización enviada: | 05/14/2018 |
| Última actualización publicada: | 06/14/2018 |
| Fecha de los primeros resultados enviados: | 01/20/2018 |
| Fecha de los primeros resultados de CC enviados: | 05/14/2018 |
| Fecha de los primeros resultados publicados: | 06/14/2018 |
| Fecha de inicio real del estudio: | 12/31/2012 |
| Fecha estimada de finalización primaria: | 05/31/2015 |
| Fecha estimada de finalización del estudio: | 05/31/2015 |
Condición o enfermedad
Intervención / tratamiento
Drug: Single group assignment - imaging
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Experimental: Single group assignment - imaging All patients will undergo PET-MR myocardial perfusion imaging during rapid intravenous administration of 0.4 mg regadenoson. | Drug: Single group assignment - imaging Regadenoson 400 micrograms will be administered in a single IV bolus (<10 seconds) via an antecubital cannula and followed by 5 mL of saline flush. 10-20 seconds after the regadenoson is administered, 10 mCi of 13N-ammonia as a bolus, and 0.075 mmol/Kg of gadobenate dimeglumine MR contrast agent at a rate of 5 mL/sec followed by a 15 mL normal saline flush will be administered simultaneous, each into an antecubital vein, and a 15 min list-mode PET acquisition will be acquired simultaneously with the MR perfusion imaging. |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - Patients who have had a clinically ordered rest/regadenoson single-isotope SPECT-MPI study within 10 days prior to cardiac PET-MRI examination - Reversible perfusion abnormalities on SPECT imaging in at least 2 contiguous myocardial segments - Patients for whom standard of care coronary ICA is planned Exclusion Criteria: - An clinical event (ie; worsening angina pectoris or myocardial infarction) occuring after the SPECT-MPI and before the cardiac MRI examination - Myocardial revascularization occuring after the SPECT-MPI and before the cardiac MRI examination - Contraindications to MR imaging (pacemaker, brain aneurysm clips, shrapnel, etc.) - Renal insufficiency (GFR < 60 mL/min/1.73m2) - Allergy or other contraindication to gadolinium-based MR contrast agent - Second or third degree atrioventricular (AV) block - Active asthma - Seizures - Current hypotension (<100/60) - Current hypertension (>160/90) - Pregnancy - Breast feeding - Use of caffeine, nicotine or over the counter cold medicines within 12 hours of the cardiac PET-MRI examination - Use of the medication dipyridamole within 48 hrs of the cardiac PET-MRI examination |
Salir
Medidas de resultado primarias
1. Diagnostic Accuracy of Cardiac PET/MRI Examination [PET/MRI imaging was performed within 10 days after SPECT-MPI examination]
