Observational - Phase II Study of Fluorine-18 3'-Deoxy-3'-Fluorothymidine (F-18-FLT) in Invasive Breast Cancer
I. To evaluate the relationship between 3'-deoxy-3'-18F fluorothymidine ([18F]FLT) uptake
parameters and pathologic complete response to chemotherapy of the primary tumor in patients
with locally advanced breast cancer.
I. To evaluate the relationship between [18F]FLT uptake parameters and the clinical
anatomical (CT) and metabolic (fludeoxyglucose [FDG] PET uptake) response.
II. To compare the utility of [18F]FLT and [18F]FDG uptake parameters for predicting early
treatment response (response assessment prior to completion of therapy) in patients with
locally advanced breast cancer.
III. To demonstrate correlation between [18F]FLT uptake parameters and tumor proliferation
markers in breast cancer.
IV. To continue to monitor for potential safety issues and define any physiologic effects
associated with [18F]FLT administration.
OUTLINE: This is a multicenter study.
On day 1, patients undergo 3'-deoxy-3'-(18F) fluorothymidine ( [18F]FLT) injection and
immediately dynamic regional positron emission tomography (PET)/CT imaging for 60 minutes,
followed by a static whole body image over approximately 30 minutes. A second static whole
body image is taken at 120 minutes post [18F]FLT injection.
On day 2, patients undergo[18F]FDG injection and PET/CT imaging 1 hour after injection. An
additional regional PET/CT image including the primary tumor in the field of view is
performed beginning at 2 hours after the injection of [18F]FDG.
Patients undergo three 2-day imaging sessions at baseline before neoadjuvant chemotherapy,
mid-neoadjuvant chemotherapy, and post-neoadjuvant chemotherapy before surgery. At the
beginning and end of each imaging session, patients complete a questionnaire indicating any
appearance or change in signs and symptoms.
After completion of neoadjuvant chemotherapy, patients undergo surgical resection of
residual tumor as planned.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Change in FLT uptake between the baseline (pre-therapy) and the early-therapy imaging studies using pathological complete response as a gold standard
To test if FLT uptake measures have any predictive (discriminating) ability, the Receiver Operating Characteristic (ROC) curve will be estimated and the area under the curve, along with its 95% confidence interval, will be determined.
Baseline to 2 years
American College of Radiology Imaging Network
United States: Food and Drug Administration
|American College of Radiology Imaging Network||Philadelphia, Pennsylvania 19103|