Trial Information

Initial Assessment of 18FDG-PET/MRI in Determining the Extent of Systemic Disease in Breast Cancer Patients.

This study is an initial assessment of the ability of 18FDG-PET/MR imaging to detect
systemic disease in breast cancer patients as compared with conventional 18FDG-PET/CT.

Rationale: Accurate assessment of the extent systemic disease in breast cancer patients both
initially and throughout treatment and surveillance comprises the basis for clinical care
including surgical planning, radiation and drug selection. Shortcomings in FDG-PET/CT, a
common current method of disease detection and surveillance, include decreased sensitivity
in brain, liver and bone and a relatively high radiation dose, which could cause up to 5 new
cancers per 1,000 patients (young American women) per scan. Initial studies assessing whole
body MRI, a technique which involves no radiation, in the staging of breast cancer patients
show promise, but can suffer from decreased ability to detect nodal disease and from
detection of false positive lesions. Manual fusion of PET and MRI data in bowel and breast
organ systems has been shown to decrease false positive lesions as compared with MRI alone.
In the past year, molecular MRI imaging machines which combine PET and MRI imaging have
become available for research purposes.

Hypothesis 1: We therefore hypothesize that FDG-PET/MRI will provide concordant or improved
lesion detection as compared with FDG-PET/CT in breast cancer patients at a decreased
radiation dose.

Hypothesis 2: In addition, the simultaneously acquired PET and MRI data allows for analysis
of local tumor characteristics including perfusion, cellularity and glucose metabolism. In
the subgroup of patients with an index breast cancer, we hypothesize that these local tumor
metrics correlate with number and sites of systemic lesions.

Methods: All newly diagnosed breast cancer patients who are undergoing imaging evaluation
for initial extent of disease or disease surveillance at NYU Cancer Center are candidates
for study in this protocol. Patients will be invited for follow-up FDG-PET/MRI imaging at
any time they are undergoing FDG-PET/CT as part of their clinical care.

Subjects are undergoing FDG-PET/CT at the Cancer Center on 34th St and Lexington Avenue as
part of routine care and will be transferred directly to the 38th St. facility by car in a
timely manner so that an additional dose of 18-FDG labeled glucose will be unnecessary for
the experimental FDG-PET/MRI.

FDG-PET/MRI will be performed and is estimated to 45-60 minutes of scanning time. The
patient will then be free to leave the department. Data will be transferred to a
workstation and interpreted by two independent radiologists. Size and location of each
lesion will be recorded in a confidentiality protected spreadsheet for each component of the
scan and the lesion load will be defined by the union of all detected lesions from all three
components (DCE-MRI, DWI, FDG-PET). Data will be compared on a per lesion, per organ system
and per patient basis with the patient's routine FDG-PET/CT for presence of metastatic
disease and size and number of metastatic lesions.

In the case where PET/MRI demonstrates metastatic disease not seen on routine modalities,
the referring physician will be alerted. Additional dedicated radiologic studies and biopsy
may be recommended and performed at the discretion of the referring physician.

Results: Results of FDG-PET/MRI and FDG-PET/CT findings will be reported in a descriptive
format together with related biopsy results and histopathologic correlation. An exact 95%
confidence interval will be derived for the true percentage of times the assessment of
disease state lesion, per organ system and per patient from FDG-PET/MRI will be concordant
with the assessments derived for the same patient using the FDG-PET/CT. In patients with an
index breast cancer, Pearson and Spearman rank correlations will be used to characterize the
association between local tumor metrics and metastatic burden and location.

Potential benefits: 1. Equal or improved ability to detect metastatic disease in breast
cancer patients at a decreased radiation dose. 2. An improved understanding of index tumor
metrics help stratify risk for metastatic disease based on the index tumor and enable
individually tailored surveillance.