Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03121989 |
| Other study ID # |
254-2015 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
Phase 1
|
| First received |
|
| Last updated |
|
| Start date |
November 21, 2017 |
| Est. completion date |
March 23, 2023 |
Study information
| Verified date |
March 2023 |
| Source |
Sunnybrook Health Sciences Centre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Objectives:
Primary Objective To assess feasibility of of acquiring time resolved, 3D 13C pyruvate MR
images of breast cancer requiring neoadjuvant chemotherapy after administration of
hyperpolarized 13C pyruvate.
Secondary Objectives
1. To determine the diagnostic accuracy of time resolved, 3D 13C pyruvate MR imaging after
administration of hyperpolarized 13C pyruvate for differentiating breast cancer from
normal breast parenchyma.
2. To spatially correlate lactate seen on hyperpolarized 13C MR to anatomic imaging with
conventional MRI.
3. To assess if hyperpolarized 13C pyruvate MR can differentiate between tumour necrosis
versus viable tumour
4. To acquire statistical information to help design, fund, and power future clinical
studies with larger patient populations.
Overall Study Design This is a pilot prospective, single-institution study in participants
who will receive NAC. Participants will be first informed of the study by personnelle within
the patient's circle of care. If the patient expresses interest in participating in the
study, the study's Clinical Research Coordinator will approach the patient to provide further
information, answer any questions, provide study documentation, as well as to obtain informed
consent if agreeable. Clinical procedures will be completed at Sunnybrook Health Sciences
Centre (SHSC) under the supervision of medically trained personnelle.
- Population: A total of 13 participants will be recruited for this study. Prior to the first
study research MRI scan, we will scan up to 3 volunteer participants with a known breast
malignancy (Group 1). These participants will not have hyperpolarized 13C pyruvate
administered. They will be scanned with a 13C phantom in order to test the functionality of
the 13C coil.
Subsequently, up to 10 volunteer participants with breast cancer requiring NAC, between 18
and 80 years of age with pathology- and imaging-confirmed breast cancer requiring NAC will be
studied (Group 2). Imaging confirmation involves highly suspicious masses on mammography
and/or ultrasound. Pathology confirmation involves image-guided core biopsy of the suspicious
mass.
- Design: Each participant will receive one research MRI scan on the 3T MRI scanner prior
to NAC. This visit will occur separately from the patient's clinical dynamic contrast
enhanced (DCE) MRI.
- Scan Timing: The research MRI exam will be scheduled before the initiation of NAC, and
within 5 days prior to, or following, the clinical MRI scan.
