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This clinical trial studies positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) in measuring tumors in patients undergoing clinical imaging or with newly diagnosed breast cancer. New diagnostic procedures, such as PET/CT or PET/MRI, may be more effective than MRI alone in measuring tumors in patients undergoing clinical imaging or with newly diagnosed breast cancer.
Full description
PRIMARY OBJECTIVES:
I. To improve visualization of tumors by developing better image reconstruction and correction methods.
II. To revise the positioning devices and, if necessary, scanner table to fit a wider size range of women.
OUTLINE:
Patients undergo clinical fludeoxyglucose F-18 (FDG)-PET/CT followed by prone breast PET/CT and/or prone breast PET/MRI with or without gadopentetate dimeglumine (DTPA).
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Inclusion criteria
[Cohorts 1 and 2] Female patients who are referred by their physician to have a clinical PET/CT
[Cohort 3] Patients referred for clinical breast dynamic contrast-enhanced (DCE)-MRI for recently diagnosed breast cancer
Normal kidney function for subjects that will receive magnetic resonance (MR) contrast agent as part of their clinical imaging
For subjects for whom MR contrast agent is to be administered, University Hospitals (UH) policy 8.17.26 will be applied
The following guidelines will be followed when a patient or patient representative responds "yes" to questions on the MRI history sheet 'Are you on dialysis, history of kidney failure, end stage renal disease, chronic liver disease, or are you a peri-liver transplant patient':
The patient must have a serum creatinine value available within three (3) weeks prior to the injection of gadolinium
Calculate an estimated glomerular filtration rate (eGFR) based on serum creatinine; if the eGFR is less than 30 the attending radiologist must discuss the risks and benefits of administering gadolinium with the referring physician and patient; the collective judgment of the patient, radiologist and referring physician must be in agreement to proceed with the injection of gadolinium
Calculated eGFR in range of 31-59 requires the judgment of the attending radiologist whether to discuss gadolinium administration with referring physician and patient or whether to directly use or hold the contrast agent
If an eGFR is greater than 60, gadolinium may be administered without further physician or patient discussion
Gadolinium administration is limited to single dose at 0.1mmol/kg; Omniscan should not be used
Technologist will document radiologist decision to administer gadolinium on the MRI history sheet; radiologist will document decision and consultation with the referring physician and patient in the MRI report
PERITONEAL DIALYSIS PATIENTS:
HEMODIALYSIS PATIENTS:
Ability to provide informed consent
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43 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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