Impact of 18F-FDG PET-CT Versus Conventional Staging in the Management of Patients Presenting With Clinical Stage III Breast Cancer

Official Title

Impact of 18F-FDG PET-CT Versus Conventional Staging in the Management of Patients Presenting With Clinical Stage III Breast Cancer

Summary:

This trial is being conducted to determine the impact of whole body FDG PET-CT vs. conventional staging in the management of patients presenting with clinical Stage III breast cancer. Eligible consenting patients with ductal or mixed histology breast cancer will be randomized 1:1 to whole body FDG PET-CT or conventional staging. Eligible consenting patients with lobular only histology will be entered into a separate single arm prospective study and will undergo whole body FDG PET-CT, CT with contrast of the chest/abdomen & pelvis and a bone scan.

Trial Description

Primary Outcome:

• Proportion of patients upstaged to Stage IV disease

• Proportion of patients who receive multimodal therapy of curative intent
• Number of additional tests, such as imaging and biopsy, resulting from findings of study imaging
• Prognostic ability of PET SUV of the primary lesion on the pathological response rate to neo-adjuvant chemotherapy
• Disease Free Survival
• Overall Survival
• Incremental economic analysis comparing the costs and outcomes of the treatment arms

View this trial on ClinicalTrials.gov