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

NCT03650803 | Completed Results FDA Device

• 1 other identifier: CASE3118
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

3D MR Fingerprinting; Quantitative MR Imaging

Outcome Measures

Primary Outcomes (2)

• Utility of Percentage Change in Longitudinal (T1) and Transverse (T2) Relaxation Times From Baseline to First Cycle of Treatment in Assessment of Response to Neo-adjuvant Chemotherapy in Breast Cancer.

  For each patient the first MRF scan was performed at the baseline before chemotherapy and the second MRF scan was performed 7-10 days after the first cycle of chemotherapy. Quantitative T1 and T2 relaxation times measured using MRF were used to characterize the breast lesions and predict the treatment response at an early phase (7-10 days after one-cycle of neoadjuvant chemotherapy). Changes in relaxation times (T1 or T2) between the baseline and 7-10 days after the first cycle of chemotherapy were used for predicting the early prediction of treatment response. Both T1 and T2 relaxation times were measured in the unit of millisecond. The unit of the measurement for this primary outcome was percentage changes of relaxation times (T1 or T2) obtained at the two different time points. The pathological results obtained after the breast surgery were used as the ground truth to determine patients response to the treatment and correlated with the findings obtained using MRF.

  2 years from start of study

• Longitudinal Relaxation (T1) and Transverse Relaxation (T2) Times of Breast Tumor

  From the 3D MR Fingerprinting maps, T1 and T2 relaxation times will be obtained from breast tumors at the baseline condition before the treatment.

  2 years from start of study

Study Arms (1)

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.

Device: 3D MR Fingerprinting scan

Interventions

3D MR Fingerprinting scan DEVICE

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.

3D MR Fingerprinting scan

Eligibility Criteria

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

You may qualify if:

• Biopsy proven cases of breast cancer

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Holly Marshall
• Organization: University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Holly.Marshall@uhhospitals.org

216-844-5330

Study Officials

• Holly Marshall, MD

  University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 29, 2018
• Study Start: January 14, 2019
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: June 20, 2024
• Results First Posted: June 20, 2024

Record last verified: 2023-08

Locations

US (1)