MR Correlated Spectroscopic Imaging for Diagnosing Breast Cancer

Non-Uniformly Sampled MR Correlated Spectroscopic Imaging in Breast Cancer and Nonlinear Reconstruction

This trial studies how well an imaging technique called magnetic resonance (MR) spectroscopic imaging works in identifying breast cancer in women with benign or suspicious areas in the breast. Magnetic resonance imaging (MRI) is a diagnostic tool used to investigate the location of tumors in different organs. Since radiological pictures do not have sufficient information for tumor grades, invasive procedure such as biopsy is performed on patients with breast cancers for diagnosis. Breast tissue contains water, fat, and chemicals known as metabolites. MR spectroscopic imaging may help to characterize the various breast metabolite steady state levels and identify the differences between necrosis and tumor recurrence, which is difficult using radiological procedures such as MRI.

Study Overview

• Status: Completed
• Conditions: Breast Carcinoma; Malignant Breast Neoplasm; Benign Breast Neoplasm
• Intervention / Treatment: Procedure: Diffusion Weighted Imaging; Procedure: Magnetic Resonance Spectroscopic Imaging

Detailed Description

PRIMARY OBJECTIVES:

I. Non-uniform undersampling schemes (NUS) will be combined with 5-dimensional (5D) echo-planar imaging based correlated spectroscopic imaging (EP-COSI) sequence.

II. Group sparsity (GS)-based compressed-sensing (CS) reconstruction schemes will be developed for accelerated acquisition and optimized to reconstruct the NUS EP-COSI data with better reliability.

III. Alterations in metabolite and lipid levels will be correlated with apparent diffusion coefficient (ADC) changes in breast cancer patients compared to healthy women which will improve the diagnostic accuracy.

OUTLINE:

Participants undergo diffusion weighted imaging (DWI)-MRI over 15 minutes and MR spectroscopic imaging over 45 minutes.

After completion of study, participants are followed up for 6 months.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA / Jonsson Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Malignant tumor subjects must have malignant needle biopsy results with concordant imaging and pathological findings.
• Benign tumor subjects must have benign needle biopsy results. Benign subjects will only include those with concordant benign imaging and pathological findings.
• Control subjects: healthy and have no previous history of any type of cancers.
• The women should be able to read and understand English. Hence, non-English speaking subjects will be excluded. However, if there will be a necessity of translating the written informed consent form in the subject's mother tongue (such as Hispanic, Chinese, Persian, Indian, etc.), the translated consent form will be submitted for expedited approval to the office of University of California, Los Angeles (UCLA) Institutional Review Board (IRB).

Exclusion Criteria:

• Pregnant women will be excluded.
• Breast feeding women.
• MR incompatible items: cardiac pacemaker, aneurysm clip, heart valve prosthesis, nitroglycerin transdermal patch, implanted cardiac defibrillator, implanted electrode, including pacing wires, cochlear implant, other, implanted drug infusion device, implanted insulin pump, intravascular coil, filter or stent: (e.g., Gianturco coil, Gunther inferior vena cava [IVC] filter, etc.), intraventricular shunt, neurostimulator/biostimulator, Swan-Ganz catheter, any type of electronic, mechanical or magnetic implant, any type of implant held in place by a magnet, artificial limb or joint, contraceptive device (e.g., intrauterine device [IUD], diaphragm), dentures, ear implant, eye/orbital implant, foreign body (e.g., shrapnel, bullet, etc.), halo vest or metallic cervical fixation device, orthopedic item (for example: pins, rods, screws, clips, plates, wires, etc.), surgical clip or staple, vascular access port, wire mesh, hearing aid (must remove prior to the exam), tattooed eyeliner (a small percentage of patients with tattooed eyeliner have experienced transient skin irritation in association with MRI). The patients using transdermal patches will be asked to remove the patch and will be excluded if the patch cannot be removed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnostic (DWI, magnetic resonance spectroscopic imaging); Participants undergo DWI over 15 minutes and MR spectroscopic imaging over 45 minutes.

Procedure: Diffusion Weighted Imaging; Undergo DWI-MRI; Other Names: DWI; DW-MRI; Diffusion Weighted MRI; Diffusion-Weighted Magnetic Resonance Imaging; Diffusion-Weighted MR Imaging; Diffusion-Weighted MRI; DWI MRI; DWI-MRI; MR Diffusion-Weighted Imaging; Procedure: Magnetic Resonance Spectroscopic Imaging; Undergo MR spectroscopic imaging; Other Names: 1H- Nuclear Magnetic Resonance Spectroscopic Imaging; 1H-nuclear magnetic resonance spectroscopic imaging; Magnetic Resonance Spectroscopy; MRS; MRS Imaging; MRSI; Proton Magnetic Resonance Spectroscopic Imaging; MS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apparent diffusion coefficient (ADC) maps	ADC maps will be calculated from diffusion weighted (DW) images by using linear regression of logarithmic intensities by using software for combinations of two, three, four, and five DW images with different b values. ADC maps will also be calculated for the remaining combinations of up to 10 evenly distributed b values. In total, 501 value combinations will be automatically processed and analyzed.	At the time of imaging

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: U.S. Army Medical Research and Development Command; U.S. Army Medical Research Acquisition Activity
• Investigators: Principal Investigator: Michael A Thomas, UCLA / Jonsson Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2017
• Primary Completion (Actual): February 3, 2023
• Study Completion (Actual): February 3, 2023

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Site; Breast Diseases; Neoplasms; Breast Neoplasms
• Other Study ID Numbers: 16-000933; NCI-2019-02258 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• 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