PET/CT or PET/MRI in Measuring Tumors in Patients Undergoing Clinical Imaging or With Newly Diagnosed Breast Cancer

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).

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:

- No gadolinium will be administered unless the patient has been
scheduled for hemodialysis within 24 hours following the injection of
gadolinium; technologist will determine eGFR and follow above
guidelines; dialysis will be scheduled by the referring physician

- HEMODIALYSIS PATIENTS:

- No gadolinium will be administered unless the patient has been
scheduled for hemodialysis within 24 hours following the injection of
gadolinium; no determination of eGFR is necessary; radiologist will
assume eGFR less than 30 and follow above guidelines; dialysis will be
scheduled by the referring physician

- Ability to provide informed consent

Exclusion Criteria:

- Subjects who do not meet all of the above inclusion criteria

- Subjects unwilling or unable to sign the informed consent form

- Subjects who are cognitively impaired and thus unable to give informed consent

- Subjects unable to undergo MR scanning due to exclusion via University Hospitals Case
Medical Center (UHCMC) MR restrictions (e.g. certain implanted metallic or electronic
devices)

- Subjects who are pregnant

- Subjects that are too large to fit comfortably into the PET/MR on the breast coil;
for cohort 1 only we will accept a maximum of 10 subjects that are too large for the
PET/MRI to acquire a prone PET/CT but without the paired PET/MR