Official Title
Impact of 18F-FDG PET-CT Versus Conventional Staging in the Management of Patients Presenting With Clinical Stage III Breast Cancer
Phase
N/ALead Sponsor
McMaster UniversityStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Stage III Breast Cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4) Stage IIb Breast Cancer (T3N0)Intervention/Treatment
Whole-body FDG PET-CT aloneStudy Participants
369This 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.
FDG PET-CT imaging
Conventional breast cancer staging consisting of a bone scan and CT imaging with contrast of the chest / abdomen & pelvis
Inclusion Criteria: Women (or men) with histological evidence of breast cancer for whom potentially curative treatment is planned. Based on clinical information (physical exam, imaging): Stage III breast cancer (T0N2, T1N2, T2N2, T3N1, 2 or T4), or Stage IIb breast cancer (T3N0), Note: T2N1 is not eligible Considered for combined modality therapy (surgical resection, chemotherapy, radiotherapy) of curative intent. Exclusion Criteria: Age < 18 years, ECOG performance status > and = 3, Prior systemic therapy (e.g. neo-adjuvant chemotherapy or hormonal therapy) for current breast cancer, Previous staging investigations for current breast cancer, Breast cancer with primary histological subtypes other than ductal or lobular (Note: Patients with mixed disease will be eligible for randomization), Clinical suspicion of metastatic disease, Relative contraindications to PET (e.g. uncontrolled diabetes (i.e. inability to decrease serum glucose below 10.2 mmol/L), claustrophobia, inability to be still for 30 minutes), Inability to lie supine for imaging with PET-CT, Inability to undergo CT because of known allergy to contrast, History of another invasive malignancy within the previous two years (exception of non melanoma skin cancer) or a synchronous primary cancer, including a synchronous contralateral breast cancer (Note: Patients found to have a contralateral breast cancer on study imaging following randomization will remain in the study), Known pregnancy or lactating female, Inability to complete the study or required follow-up.
