Clinical Effectiveness of CEM in Diagnosis of Additional Findings at Preoperative Breast Magnetic Resonance Imaging

NCT06475066 | Not Yet Recruiting

• 1 other identifier: UHCT230291
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

In order to explain the value of adding CESM into the clinical pathway, and also to obtain the relevant clinical data to support future update of clinical guideline, we plan to evaluate the detection rate of CESM for additional findings on preoperative breast MRI and the relevant clinical safety in the study.

Conditions

Breast Cancer

Keywords

Multicentric Lesion; Multifocal Lesion; Contrast Enhanced Spetral Mammography

Outcome Measures

Primary Outcomes (1)

• The detection rate of preoperative contrast-enhanced spectral mammography

  The detection rate of preoperative contrast-enhanced spectral mammography in 28 days after breast MRI for the detection of additional MRI findings in patients with breast index lesions (BI-RADS ≥ 4). The efficacy analysis data set of the study included all subjects who have obtained breast MRI and CESM with adequate image quality (score ≥ 2 of the 1-5 rating scale).

  within 28 days of MRI examination

Secondary Outcomes (5)

• detection rate

  within 28 days of MRI examination

• Number of Participants with change of treatment plan from baseline

  within 28 days of MRI examination

• Number of Participants with change of biopsy plan from baseline

  within 28 days of MRI examination

• diagnostic accuracy of CESM

  within 28 days of MRI examination

• difference by MRI and CESM

  within 28 days of MRI examination

Other Outcomes (2)

• Safety Outcomes

  During imaging procedure, 1 hour

• Safety Outcomes

  During imaging procedure, 1 hour

Study Arms (1)

Contrast-enhanced spectral mammography arm

EXPERIMENTAL

Subjects receiving contrast-enhanced spectral mammography (CESM) within 28 days of MRI examination.

Diagnostic Test: contrast-enhanced spectral mammography

Interventions

contrast-enhanced spectral mammography DIAGNOSTIC_TEST

After enrollment, subjects should undergo contrast-enhanced spectral mammography again within within 28 days of MRI examination. Iopromide/contrast agent is intravenously administered two minutes prior to the first (dual-energy) image acquisition. * The dosage of iodine contrast agent is calculated as 1.5 mL/kg of iopromide 370 mgI/ml. * Injecting with high pressure syringe (Stellant, Bayer AG) at an IDR of 3ml/s, followed by 10 ml normal saline.

Also known as: CEM, CESM

Contrast-enhanced spectral mammography arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Adult women aged 18-75 years old
• \. First-time referral to the breast clinic or inpatient department of the study center for being diagnosed as presenting with suspicious breast lesions by previous procedures in 30 days
• \. Presenting with Index lesions of "BI-RADS≥4" and additional findings in preoperative breast MRI
• \. Sign the informed consent form for this study.
• \. Commit to follow the research procedures and cooperate with the implementation of the whole process of the study.
• \. In the case of women of childbearing age, have been taken contraception for at least one month prior to screening and have had a negative serum or urine pregnancy test and commit to use contraception throughout the study period

You may not qualify if:

• \. Patients with contraindications of intravenous administration of iodine contrast agent, such as pregnant or lactating women, patients with a history of iodine contrast agent allergy, patients with obvious hyperthyroidism
• \. It has been more than 14 days since the most recent preoperative breast MRI was performed for the relevant breast disease
• \. For the relevant breast disease, the preoperative breast MRI images and reports received within 14 days before screening are not available or do not meet the requirements of clinical diagnosis
• \. Patients who is receiving non-surgical interventional treatment such as neoadjuvant chemotherapy, hormone therapy or radiation therapy
• \. Patients who have received any breast operation for the relevant disease, such as various biopsies, therapeutic breast surgery
• \. Other patients assessed by the investigators as not suitable for the study, such as those who are difficult to cooperate with CESM examination due to unconsciousness, communication disorder or/and small breasts to meet the examination requirements

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Fan Yang, Dr.

  Union Hospital of Tongji Medical College of Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fan Yang, Dr.

CONTACT

008685726114; fyang@vip.163.com

Juan Tao, Dr.

CONTACT

008685726114; taojuan@hust.edu.cn

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: April 10, 2024
• First Posted: June 26, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)