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

NCT02679586 | Completed Early Phase 1 DMC

• 2 other identifiers: UMCC 2006.010HUM00003392
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 \[PD\]).

  baseline and 8-11 days post treatment

Secondary Outcomes (2)

• Change in relative tumor volume with increasing apparent diffusion coefficient between baseline and 8-11 days of chemotherapy

  baseline and 8-11 days post treatment

• Change in relative tumor volume with decreasing apparent diffusion coefficient between baseline and 8-11 days of chemotherapy

  baseline and 8-11 days post treatment

Study Arms (1)

Diffusion weighted MRI Group

EXPERIMENTAL

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.

Device: Diffusion weighted MRI

Interventions

Diffusion weighted MRI DEVICE

Also known as: DW-MRI

Diffusion weighted MRI Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0944, United States

Location

Related Publications (1)

• 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.

  PMID: 25816249 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diffusion Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Magnetic Resonance Imaging; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Norah L Henry, M.D., Ph.D.

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 10, 2016
• Study Start: June 1, 2006
• Primary Completion: March 1, 2013
• Last Updated: February 11, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)