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Imaging Biomarker for Early Detection of Treatment Efficacy During Breast Cancer Neoadjuvant Chemotherapy

Primary Purpose

Breast Cancer

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Diffusion weighted MRI
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Michigan Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diffusion weighted MRI Group

Arm Description

All patients will receive a double baseline diffusion weighted MRI (performed on the same day as the Baseline MRI). Patients participating in Part I will receive another MRI approximately 1 week (day 8-11) after the first dose of Chemotherapy (chemotherapy will be determined by the treating physician and is not assigned as part of this trial). Patients participating in Part II will receive a single MRI 1-2 weeks after the first dose of Chemotherapy A (chemotherapy will be determined by the treating physician and is not assigned as part of this trial). A second MRI will be repeated within 2 weeks prior to the start of Chemotherapy B.

Outcomes

Primary Outcome Measures

Percent change in apparent diffusion coefficient between baseline and 8-11 days after chemotherapy
Percent change in apparent diffusion coefficient was determined by calculating the percentage change between the value prior to chemotherapy and at 8-11 days post treatment for treatment responders (patients with Complete Response [CR] or Partial Response [PR]) and for the treatment non-responders (patients with Stable Disease [SD] or Progressive Disease [PD]).

Secondary Outcome Measures

Change in relative tumor volume with increasing apparent diffusion coefficient between baseline and 8-11 days of chemotherapy
Determine, by Parametric Response Map (PRM), the percent relative tumor volume with increasing ADC in responders (patients with Complete Response [CR] or Partial Response [PR]) and non-responders (patients with Stable Disease [SD] or Progressive Disease [PD].
Change in relative tumor volume with decreasing apparent diffusion coefficient between baseline and 8-11 days of chemotherapy
Determine, by Parametric Response Map (PRM), the percent relative tumor volume with decreasing ADC in responders (patients with Complete Response [CR] or Partial Response [PR]) and non-responders (patients with Stable Disease [SD] or Progressive Disease [PD].

Full Information

First Posted
February 5, 2016
Last Updated
February 10, 2016
Sponsor
University of Michigan Rogel Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT02679586
Brief Title
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

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan Rogel Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diffusion weighted MRI Group
Arm Type
Experimental
Arm Description
All patients will receive a double baseline diffusion weighted MRI (performed on the same day as the Baseline MRI). Patients participating in Part I will receive another MRI approximately 1 week (day 8-11) after the first dose of Chemotherapy (chemotherapy will be determined by the treating physician and is not assigned as part of this trial). Patients participating in Part II will receive a single MRI 1-2 weeks after the first dose of Chemotherapy A (chemotherapy will be determined by the treating physician and is not assigned as part of this trial). A second MRI will be repeated within 2 weeks prior to the start of Chemotherapy B.
Intervention Type
Device
Intervention Name(s)
Diffusion weighted MRI
Other Intervention Name(s)
DW-MRI
Primary Outcome Measure Information:
Title
Percent change in apparent diffusion coefficient between baseline and 8-11 days after chemotherapy
Description
Percent change in apparent diffusion coefficient was determined by calculating the percentage change between the value prior to chemotherapy and at 8-11 days post treatment for treatment responders (patients with Complete Response [CR] or Partial Response [PR]) and for the treatment non-responders (patients with Stable Disease [SD] or Progressive Disease [PD]).
Time Frame
baseline and 8-11 days post treatment
Secondary Outcome Measure Information:
Title
Change in relative tumor volume with increasing apparent diffusion coefficient between baseline and 8-11 days of chemotherapy
Description
Determine, by Parametric Response Map (PRM), the percent relative tumor volume with increasing ADC in responders (patients with Complete Response [CR] or Partial Response [PR]) and non-responders (patients with Stable Disease [SD] or Progressive Disease [PD].
Time Frame
baseline and 8-11 days post treatment
Title
Change in relative tumor volume with decreasing apparent diffusion coefficient between baseline and 8-11 days of chemotherapy
Description
Determine, by Parametric Response Map (PRM), the percent relative tumor volume with decreasing ADC in responders (patients with Complete Response [CR] or Partial Response [PR]) and non-responders (patients with Stable Disease [SD] or Progressive Disease [PD].
Time Frame
baseline and 8-11 days post treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norah L Henry, M.D., Ph.D.
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0944
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25816249
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.
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Imaging Biomarker for Early Detection of Treatment Efficacy During Breast Cancer Neoadjuvant Chemotherapy

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