Study to Evaluate the Feasibility of 13-C Pyruvate Imaging in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Breast cancer is the second most common form of cancer in women and the most frequent cause of death. Despite breast screening programs, a substantial number of women are diagnosed with cancers greater than 2 cm in size or locally advanced disease, which is best treated with neoadjuvant chemotherapy (NAC) prior to surgery. Approximately 10% of women diagnosed with breast cancer annually will have locally advanced breast cancer, defined as stage III disease, where the cancer has either spread to regional lymph nodes and/or other tissue in the area of the breast, but not to distant sites. NAC offers the advantages of downstaging the disease, potentially reducing the extent of surgery. Presently, gadolinium enhanced MRI is the standard test used to monitor disease response to chemotherapy, and demonstrates changes in tumour size and extent between pre-NAC and post-NAC. Unfortunately, changes in tumour size may occur late in treatment regimen, thus producing false-negative results on early magnetic resonance imaging (MRI). Therefore, newer imaging techniques beyond anatomical imaging are needed to identify tumours that are unresponsive to chemotherapy and potentially change treatment plan early on to avoid significant morbidity associated with prolonged chemotherapy.

A novel MRI technique utilizing hyperpolarized pyruvate has the potential to detect pathophysiological response early in the treatment regimen and would therefore allow for earlier identification of nonresponders and subsequent early modification of treatment regimens, if necessary.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre

Criteria

Inclusion Criteria:

• Adult participants of all ethnic groups/ race categories (age: between 18 and 80 years old)

• Radiographic diagnosis and pathologic confirmation of breast cancer

• Undergoing NAC prior to breast-conservation surgery (not applicable to the 3 participants not receiving the injection)

• Estimated survival more than 1 month

• Informed consent

• The participant will also be asked to complete the standard MRI safety screening questionnaire, prior to their research scan and participation in the study.

• Negative pregnancy test for females of child bearing potential

• Aspartate aminotransferase (AST) <31 U/L

• Alanine aminotransferase (ALT) <31 U/L

• Creatinine 44 - 106 umol/L

Exclusion Criteria:

• Contraindication to MRI or intravenous contrast agents

• Women that are pregnant or breastfeeding

• Participants weighing >136 kgs (weight limit for the scanner tables)

• Participants with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices not compatible with MRI.

• Pregnant

• Claustrophobia

• Inability to lie still for 45-60 minutes

• Participants with a high risk factor for nephrogenic systemic fibrosis (NFS), including renal failure on dialysis, heart disease, diabetes, single kidney, hypertension/hypotension, multiple myeloma, peripheral vascular disease, or taking of specific medications (loop diuretics, NSAIDs (within 7 days of research MRI), aminoglycosides, vancomycin, amphotericin B, chemotherapy, or immunosuppressants).