Clinical Trial: NCT03650803 - My Cancer Genome

NCT03650803

Description:

The purpose of this study is to determine if new methods of MRI imaging can better measure participants' response to chemotherapy treatment.

Related Conditions:

Breast Carcinoma

Recruiting Status:

Recruiting

Phase:

N/A

URL:

https://clinicaltrials.gov/show/NCT03650803

Trial Eligibility

Document

Title

Brief Title: Role of Magnetic Resonance Fingerprinting and Quantitative MR Imaging in Breast Cancer
Official Title: Role of Magnetic Resonance Fingerprinting and Quantitative MR Imaging in Assessment of Response to Neo-Adjuvant Chemotherapy in Breast Cancer

Clinical Trial IDs

ORG STUDY ID: CASE3118
NCT ID: NCT03650803

Conditions

Breast Cancer

Purpose

The purpose of this study is to determine if new methods of MRI imaging can better measure participants' response to chemotherapy treatment.

Detailed Description

      The objectives of this study are to assess the utility of quantitative Magnetic Resonance
      Imaging (MRI) in assessment of response to neo-adjuvant chemotherapy in breast cancer.
      Magnetic Resonance (MR) Fingerprinting based relaxometry allows quantification of T1 and T2
      relaxation times of tumor and normal breast tissue. Response to chemotherapy is associated
      with measurable changes in these properties and may be used to predict treatment response
      earlier than conventional MRI. The study team hypothesize that 3D MRF before, during and
      after chemotherapy can provide additional quantitative information about changes during
      treatment and may predict early response to chemotherapy.

      During visit 1, 3D MR Fingerprinting images will be added to the clinical MRI scan before
      start of chemotherapy. The additional research images will take less than 20 minutes to
      acquire During visit 2, patients will be scheduled for a research only non-contrast 3D MR
      Fingerprinting scan 7-10 days after the first cycle of chemotherapy. Acquisition of images
      will take approximately 30 minutes.

      During visit 3, if the treating physician orders a clinical MRI scan within 1 month of the
      end of chemotherapy treatment, the investigators will add a 3D MR Fingerprinting sequence to
      the clinical scan. The additional research images will take less than 20 minutes to acquire.
      If the patient is not scheduled for a clinical scan within 1 month of the end of chemotherapy
      treatment, the investigators will contact the patient to schedule a research only 3D MR
      Fingerprinting scan. The study team would like to administer IV gadolinium contrast for
      research purposes. Patients will be reconsented prior to the research only scan to determine
      whether or not they will receive IV contrast. If the patient declines administration of
      contrast for the post treatment scan, the study team will perform a non-contrast scan.
      Acquisition of images will take 30-45 minutes.

Trial Arms

Name	Type	Description	Interventions
3D MR Fingerprinting scan	Experimental	Three separate 3D MR fingerprinting scans: Before the start of chemotherapy, 7-10 days after the first cycle of chemotherapy, and within 1 month of the end of chemotherapy treatment.

Eligibility Criteria

        Inclusion Criteria:

          -  Biopsy proven cases of breast cancer

        Exclusion Criteria:

          -  Patients with onlybenign lesion

          -  Patients with onlyductal carcinomain situ (DCIS)

          -  Patients with recurrent/ residual breast cancer in same breast

          -  Pregnant women

          -  Lactating Women6.Patients with ferromagnetic or otherwise non-MRI compatible aneurysm
             clips.

          -  The presence of an implanted medical device that is not MRI-compatible, including, but
             not limited to: pacemaker, defibrillator

          -  Patients with contraindications for MRIdue to embedded foreign metallic objects.
             Bullets, shrapnel, metalwork fragments, or other metallic material adds unnecessary
             risk to the patient.

          -  Known history of severe claustrophobia

          -  Patients under the age of 18

          -  For patients with known history of allergic reaction to MR contrast material or
             abnormal kidney function (GFR < 40 mL/ min), a contrast enhanced exam will not be
             performed; however, a non-contrast exam may be performed in these patients.

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	Female
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Utility of quantitative MRI in assessment of response to neo-adjuvant chemotherapy in breast cancer
Time Frame:	2 years from start of study
Safety Issue:
Description:	Final surgicopathology results would be used for response assessment. Thus pathology reports with pT0N0 would be designated as pathological complete response while pT0 but with residual nodal deposits on pathology would be considered as primary tumor response for analysis purpose. Presence of any residual tumor on pathology would be considered as non-responder. In the sub-group of patients who fail to undergo surgery at the end of treatment, RECIST version 1.1 criteria would be considered as surrogate criteria for response (1). Thus no visible tumor and nodes at end of treatment scan will be considered complete response, >30% decrease in long-axis diameter (LAD) compared to baseline will be partial response, > 20% increase in LAD will be progressive disease while < 30% decrease/ > 20% increase in LAD will be considered stable disease

Details

Phase:	N/A
Primary Purpose:	Interventional
Overall Status:	Recruiting
Lead Sponsor:	Case Comprehensive Cancer Center

Trial Keywords

3D MR Fingerprinting
Quantitative MR Imaging

Last Updated

February 21, 2021

Clinical Trials /

Role of Magnetic Resonance Fingerprinting and Quantitative MR Imaging in Breast Cancer