MR Correlated Spectroscopic Imaging for Diagnosing Breast Cancer

NCT06090630 | Completed Early Phase 1 FDA Device

• 2 other identifiers: 16-000933NCI-2019-02258
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Benign Breast Neoplasm; Breast Carcinoma; Malignant Breast Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Diagnostic (DWI, magnetic resonance spectroscopic imaging)

EXPERIMENTAL

Participants undergo DWI over 15 minutes and MR spectroscopic imaging over 45 minutes.

Procedure: Diffusion Weighted Imaging; Procedure: Magnetic Resonance Spectroscopic Imaging

Interventions

Diffusion Weighted Imaging PROCEDURE

Undergo DWI-MRI

Also known as: Diffusion Weighted MRI, Diffusion-Weighted Magnetic Resonance Imaging, Diffusion-Weighted MR Imaging, Diffusion-Weighted MRI, DW-MRI, DWI, DWI MRI, DWI-MRI, MR Diffusion-Weighted Imaging

Diagnostic (DWI, magnetic resonance spectroscopic imaging)

Magnetic Resonance Spectroscopic Imaging PROCEDURE

Undergo MR spectroscopic imaging

Also known as: 1H- Nuclear Magnetic Resonance Spectroscopic Imaging, 1H-nuclear magnetic resonance spectroscopic imaging, Magnetic Resonance Spectroscopy, MRS, MRS Imaging, MRSI, MS, Proton Magnetic Resonance Spectroscopic Imaging

Diagnostic (DWI, magnetic resonance spectroscopic imaging)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• U.S. Army Medical Research and Development Command: collaborator
• U.S. Army Medical Research Acquisition Activity: collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Michael A Thomas

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: October 19, 2023
• Study Start: July 31, 2017
• Primary Completion: February 3, 2023
• Study Completion: February 3, 2023
• Last Updated: April 17, 2024

Record last verified: 2023-07

Locations

US (1)