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American Family Children's Hospital

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Protocol No. UW15026

Principal Investigator Fowler, Amy

Phase N/A

Age Group Adult

Scope Local

Sponsor Type Industry; Institutional

Title Breast MR/PET Imaging Protocol Development and Validation

Objective The purpose of this research study is to compare a different type of PET scan (PET combined with magnetic resonance imaging or PET/MR) to a PET/CT (PET combined with computed tomography or CT) scan. This information will help us develop and implement PET/MR for diagnosing, staging, and monitoring treatment response in patients diagnosed with breast cancer.

Treatment You will be asked to complete one study visit that will include both a breast PET/MRI scan and a breast PET/CT scan. This visit will be scheduled before any surgeries that may be required to treat your breast cancer.

Description At the study visit, the research nurse will collect your height and weight. If you have a history of diabetes, a blood glucose measurement will be completed. An IV will be placed in a vein in your arm and the PET tracer (FDG) will be injected. You will be required to sit quietly for 60 minutes while the tracer circulates through your body. You will then be placed in the PET/CT scanner and images will be collected over approximately 10 minutes. Once the PET/CT has been completed, you will be moved to the PET/MRI scanner. Images will take approximately 30 to 40 minutes to collect.

Key Eligibility
  • Recent diagnosis of biopsy-proven invasive breast cancer measuring at least two (2) cm in diameter by mammography, ultrasound, or clinical breast MRI
  • Undergoing diagnostic breast MRI ordered by the referring clinician for staging and extent of disease
  • Patients with a history of diabetes will have their serum glucose level checked prior to administration of 18F-FDG to ensure a blood glucose level below 200 mg/dl
  • Patients planning to receive neoadjuvant chemotherapy/endocrine therapy after the clinical breast MRI and before the research breast MR/PET examination, those currently undergoing neoadjuvant chemotherapy/endocrine therapy, or those who have received chemotherapy/endocrine therapy within 6 months prior to the MRI are ineligible
  • Patients who have had surgical intervention or radiation for the current biopsy-proven malignancy are ineligible
  • Patients with breast implants or expanders are ineligible
  • Patients who are or might be pregnant or lactating are ineligible
  • If patient weight exceeds table limit for the PET/CT scanner (400 pounds) they are ineligible
  • Patients with standard contraindications to MRI, including claustrophobia and metallic implants incompatible with MRI are ineligible
  • Patients requiring conscious sedation for imaging are ineligible
  • Each patient can only enroll once within the time period of the study

Applicable Disease Sites Breast

Status Open

Participating Institutions UW Hospital and Clinics