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

NCT ID: NCT02679586

Last Updated: 2016-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diffusion weighted MRI Group

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.

Group Type: EXPERIMENTAL

Diffusion weighted MRI

Intervention Type: DEVICE

Interventions

Diffusion weighted MRI

Intervention Type: DEVICE

Other Intervention Names

DW-MRI

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Lynn Henry

Associate Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Norah L Henry, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 25816249 (View on PubMed)

Other Identifiers

HUM00003392

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2006.010

Identifier Type: -

Identifier Source: org_study_id