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

Completed · Early Phase 1

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02679586

Run by

University of Michigan Rogel Cancer Center

People needed

25

Starts

2006-06-01

Last updated by the study team

2016-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• University of Michigan Comprehensive Cancer Center — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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