Status:
COMPLETED
MR Correlated Spectroscopic Imaging for Diagnosing Breast Cancer
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
U.S. Army Medical Research Acquisition Activity
Conditions:
Benign Breast Neoplasm
Breast Carcinoma
Eligibility:
FEMALE
18-80 years
Phase:
EARLY_PHASE1
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. Magneti...
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 spars...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2023
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT06090630
Start Date
July 31 2017
End Date
February 3 2023
Last Update
April 17 2024
Active Locations (1)
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1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095