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

Primary Purpose

Breast Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3D MR Fingerprinting scan
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring 3D MR Fingerprinting, Quantitative MR Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

3D MR Fingerprinting scan

Arm Description

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.

Outcomes

Primary Outcome Measures

Utility of quantitative MRI in assessment of response to neo-adjuvant chemotherapy in breast cancer
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
Longitudinal relaxation (T1) and transverse relaxation (T2) relaxation times of tumor and normal breast tissue.
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

Secondary Outcome Measures

Full Information

First Posted
August 27, 2018
Last Updated
June 6, 2022
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03650803
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
3D MR Fingerprinting, Quantitative MR Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3D MR Fingerprinting scan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
3D MR Fingerprinting scan
Intervention Description
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 Measure Information:
Title
Utility of quantitative MRI in assessment of response to neo-adjuvant chemotherapy in breast cancer
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
Time Frame
2 years from start of study
Title
Longitudinal relaxation (T1) and transverse relaxation (T2) relaxation times of tumor and normal breast tissue.
Description
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
Time Frame
2 years from start of study

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly Marshall, MD
Organizational Affiliation
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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