Clinical Trial of the Week: Diagnostic device trial for patients with metastatic breast cancer

By Donna Loyle, communications manager, LIMR


Researchers, including those at MLH, seek to evaluate the performance of fludeoxyglucose F-18 (FDG)-PET/CT response criteria as a binary predictor of progression-free survival in patients with bone-dominant metastatic breast cancer treated with systemic therapy.


Participants in this phase II, non-randomized clinical trial receive FDG intravenous solution and undergo PET/CT scan over 15 to 30 minutes within 21 days before start of standard treatment, and then again at 12 weeks after start of standard treatment.


Inclusion criteria:

  • Must have been diagnosed with metastatic breast cancer that is hormone-receptor positive and with known HER2 status and whose cancer has spread only or predominantly to the bones
  • Must be able to undergo FDG-PET imaging
  • Must be undergoing a systemic therapy such as endocrine therapy, chemotherapy or an HER2-targeted treatment
  • Other inclusion and exclusion criteria apply


Study #EA1183 is approved for all MLH acute care hospitals. The principal investigator is Paul Gilman, MD. For more, email or visit

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