Clinical trial NCT02679586: Imaging Biomarker for Early Detection of Treatment Efficacy During Breast Cancer Neoadjuvant Chemotherapy
Official title: Evaluation of an Imaging Biomarker for Early Detection of Treatment Efficacy During Breast Cancer Neoadjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2016-02-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a single-arm, single-institution pilot study that will collect preliminary data to be used in the design of a subsequent study to assess whether changes in fDM (Functional Diffusion Maps) derived from primary breast cancer diffusion weighted MRI images can serve as an early predictor of response to treatment, and whether the magnitude of the change correlates with the effectiveness of treatment.

Detailed description: This trial has a two-step, sequential design, with continuation to the second part of the trial being dependent on the positive results in the first part. In Part One of the trial, the investigator will compare intrapatient variability in fDM performed at two timepoints prior to chemotherapy (chemotherapy will be chosen by the treating physician and will not be assigned as part of this study), with the change in fDM before and approximately one week after a dose of chemotherapy, to establish that treatment-related changes in fDM will occur in this clinical setting. If there are positive results in Part One, then the investigator will proceed to the second half of the trial. In Part Two, the investigator will examine changes in fDM that occur one week after each type of chemotherapy is administered, which will be compared to pathologic response, radiological response, and clinical response.

Eligibility criteria: Inclusion Criteria:

* Patients must have a primary measurable, biopsy proven, invasive breast carcinoma with the primary tumor intact. The tumor should be staged clinically as T2-T4 (minimum size \>2.0 cm).
* Patients must have a breast tumor that is resectable or potentially resectable following neoadjuvant chemotherapy and be willing to undergo resection, if indicated, after chemotherapy.
* Patients may not have received prior chemotherapy or radiation therapy for their current breast cancer.
* Patients may not have had a clip placed into the tumor that is not compatible with MRI.
* Patients must be deemed eligible for neoadjuvant chemotherapy, as assessed by the clinical investigator.
* Age \> 18 years.
* Patients must have an ECOG performance status (Eastern Cooperative Oncology Group Performance Status: an attempt to quantify cancer patients' general well-being and activities of daily life. The score ranges from 0 to 5 where 0 is asymptomatic and 5 is death.) of 0 - 1.
* Patients must not be pregnant or breast-feeding. Patients with reproductive potential must consent to the use of effective contraception while on the study.
* Patients must have no contraindications to MRI (Magnetic Resonance Imaging) exams. Patients who require sedation with general anesthesia to complete an MRI are not eligible for the study.
* Patients may have no ferrous metal implants or medical devices which would exclude MRI.
* Patients must be capable of lying flat in an MRI magnet for 30-60 minutes on 4 occasions.
* Weight must be less than 275 pounds.
* Patients must have the ability to understand and willingness to sign a written informed consent document.

Primary outcomes:
measure: Percent change in apparent diffusion coefficient between baseline and 8-11 days after chemotherapy
timeFrame: baseline and 8-11 days post treatment
Secondary outcomes:
measure: Change in relative tumor volume with increasing apparent diffusion coefficient between baseline and 8-11 days of chemotherapy
timeFrame: baseline and 8-11 days post treatment
measure: Change in relative tumor volume with decreasing apparent diffusion coefficient between baseline and 8-11 days of chemotherapy
timeFrame: baseline and 8-11 days post treatment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Norah L Henry, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Galban CJ, Ma B, Malyarenko D, Pickles MD, Heist K, Henry NL, Schott AF, Neal CH, Hylton NM, Rehemtulla A, Johnson TD, Meyer CR, Chenevert TL, Turnbull LW, Ross BD. Multi-site clinical evaluation of DW-MRI as a treatment response metric for breast cancer patients undergoing neoadjuvant chemotherapy. PLoS One. 2015 Mar 27;10(3):e0122151. doi: 10.1371/journal.pone.0122151. eCollection 2015.