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Clinical Trial VICCBRE09108


PET/CT Evaluation of Treatment Response in Breast Cancer

Principal Investigator(s)

Bapsi Chak


  • Protocol No. VICCBRE09108
  • Open Date: 10/13/2010
  • Staging: N/A
  • Age Group: Adults
  • Scope: Local
  • Objective: To develop PET/CT methods for assessing the effects of chemotherapy in breast cancer. To provide the breast cancer community with practical data acquisition and analysis protocols that facilitate the translation of advanced PET/CT imaging technologies into patient management and clinical trials. To compare and combine MRIs (obtained from an ongoing imaging study BRE0588) and PET/CT methods (obtained from the current study) to develop a robust assessment of tumor status.
  • Disease Sites: Breast
  • Therapies: None Specified
  • Drugs: None Specified
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01222416
  • Secondary Protocol No: Not Specified


You are being asked to take part in this research study because you have been diagnosed with Breast Cancer. Although mammography and ultrasound imaging play a critical role in the detection and diagnosis of breast cancer, there are currently no reliable radiological methods for assessing the response of tumors to treatments to guide clinical decisions. The development of appropriate methods of tissue characterization that could be applied early in the course of treatment to assess response would allow clinicians to tailor therapy for an individual patient based on each patient-s response to a particular agent.


Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Female
Accepts Healthy Volunteers:No


Inclusion Criteria:
• Subjects must have histologically proven breast cancer
• Subjects are being considered for preoperative chemotherapy
• Subjects must be ≥ 18 years old.
Exclusion Criteria:
• Children will be excluded from this study.
• Pregnant women and women who are breast feeding will be excluded from this study. (The "PET Procedure Screening Form" will be used to identify and exclude subjects who are pregnant or breastfeeding. A urine pregnancy test/or serum beta HCG will also be performed for women of child bearing potential)
• Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study