Breast CancerNCT03650803

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

A study testing 3D MR Fingerprinting scan in people with Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: 3D MR Fingerprinting scan
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: 14 Jan 2019to 1 Apr 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Biopsy proven cases of breast cancer

Who cannot join

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

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Breast Cancer
Being tested: 3D MR Fingerprinting scan
Keywords: 3D MR Fingerprinting, Quantitative MR Imaging
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

3D MR Fingerprinting scanDevice
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.

Study groups in NCT03650803
Study group	Role	What they receive
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. Receives: Device: 3D MR Fingerprinting scan

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 2 years from start of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jan 20191 Apr 2023

First posted29 Aug 2018
Study start14 Jan 2019
Primary completion1 Apr 2023
Study completion1 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03650803
Sponsor's protocol ID: CASE3118
Status last verified: Aug 2023
First submitted: 27 Aug 2018
Last updated: 20 Jun 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Role of Magnetic Resonance Fingerprinting and Quantitative MR Imaging in Assessment of Response to Neo-Adjuvant Chemotherapy in Breast Cancer
ClinicalTrials.gov ID: NCT03650803
Acronym / sponsor ID: CASE3118
Conditions: Breast Cancer
Keywords: 3D MR Fingerprinting, Quantitative MR Imaging
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Case Comprehensive Cancer CenterUniversity, hospital or other
Study start: 14 Jan 2019 (actual)
Primary completion: 1 Apr 2023 (actual)
Study completion: 1 Apr 2023 (actual)
First posted: 29 Aug 2018 (actual)
Results: Posted 20 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
3D MR Fingerprinting scan	Experimental	Device: 3D MR Fingerprinting scanThree 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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Biopsy proven cases of breast cancer

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
3D MR Fingerprinting scan3D 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.	Device	3D MR Fingerprinting scan

Primary outcome

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.
Time frame: 2 years from start of study
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.
Longitudinal Relaxation (T1) and Transverse Relaxation (T2) Times of Breast Tumor
Time frame: 2 years from start of study
From the 3D MR Fingerprinting maps, T1 and T2 relaxation times will be obtained from breast tumors at the baseline condition before the treatment.

Results and safety

Results posted to the registry on 20 Jun 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
3D MR Fingerprinting Scan	14	8

Primary outcome: 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.

Time frame: 2 years from start of study. Mean (Standard Deviation). Unit: Percentage change of relaxation time

Measure	Responders to 3D MR Fingerprinting Scan n = 3	Non-Responders to 3D MR Fingerprinting Scan n = 5
MRF T1 Changes	-19.8 (19.3)	5.4 (9.9)
MRF T2 Changes	-21.4 (4.2)	-7.1 (10.2)

Responders to 3D MR Fingerprinting Scan vs Non-Responders to 3D MR Fingerprinting Scan: p = 0.046, t-test, 1 sided
Responders to 3D MR Fingerprinting Scan vs Non-Responders to 3D MR Fingerprinting Scan: p = 0.064, t-test, 2 sided

Population analysed: Only the participants who have completed at least the first two MRF scans were included in this data analysis. Six participants are excluded due to being lost to follow-up.

Primary outcome: Longitudinal Relaxation (T1) and Transverse Relaxation (T2) Times of Breast Tumor

Time frame: 2 years from start of study. Mean (Standard Deviation). Unit: milliseconds

Measure	Responders to 3D MR Fingerprinting Scan n = 3	Non-Responders to 3D MR Fingerprinting Scan n = 5
MRF T1 values before treatment	1304.3 (121.5)	1264.6 (266.6)
MRF T2 values before treatment	77.0 (6.6)	68.8 (24.8)

Responders to 3D MR Fingerprinting Scan vs Non-Responders to 3D MR Fingerprinting Scan: p = 0.820, t-test, 2 sided
Responders to 3D MR Fingerprinting Scan vs Non-Responders to 3D MR Fingerprinting Scan: p = 0.605, t-test, 2 sided

Population analysed: Only the participants who have completed at least the first two MRF scans were included in this data analysis. Six participants are excluded due to being lost to follow-up.

Adverse events

Time frame: Adverse events were monitored through study completion, up to 6 months for each enrolled patient.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
3D MR Fingerprinting Scan	0 of 14 (0%)	1 of 14 (7.1%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Holly Marshall, MD principal investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing 3D MR Fingerprinting scan in people with Breast Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 2 years from start of study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03650803.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.