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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03650803
Recruitment Status : Active, not recruiting
First Posted : August 29, 2018
Last Update Posted : June 7, 2022
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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

Condition or disease Intervention/treatment Phase
Breast Cancer Device: 3D MR Fingerprinting scan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Role of Magnetic Resonance Fingerprinting and Quantitative MR Imaging in Assessment of Response to Neo-Adjuvant Chemotherapy in Breast Cancer
Actual Study Start Date : January 14, 2019
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 3D MR Fingerprinting scan
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.
Device: 3D MR Fingerprinting scan

3D MR Fingerprinting technique is a non-contrast technique and generates quantitative information about MR-visible tumors without having to administer contrast.

MR Fingerprinting software is used in conjunction with a standard-of-care MRI scan.





Primary Outcome Measures :
  1. Utility of quantitative MRI in assessment of response to neo-adjuvant chemotherapy in breast cancer [ Time Frame: 2 years from start of study ]
    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

  2. Longitudinal relaxation (T1) and transverse relaxation (T2) relaxation times of tumor and normal breast tissue. [ Time Frame: 2 years from start of study ]
    From the 3D MR Fingerprinting maps, T1 and T2 relaxation times will be obtained for tumor, and peritumoral and normal breast tissue at all three scans



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650803


Locations
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United States, Ohio
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Holly Marshall, MD University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03650803    
Other Study ID Numbers: CASE3118
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: June 7, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Case Comprehensive Cancer Center:
3D MR Fingerprinting
Quantitative MR Imaging
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases