Diagnostic accuracy of portable breast tumor detector

JRCT ID: jRCTs062180005

Registered date:07/11/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Breast cancer, Benign breast tumor
• Date of first enrollment: 26/11/2018
• Target sample size: 120
• Study type: Interventional
• Intervention(s): Measurement of bilateral breast using study device

Outcome(s)

• Primary Outcome: Sensitivity and specificity of breast cancer and benign breast tumor by portable breast tumor detector.

Secondary Outcome

1.Sensitivity of breast cancer according to molecular subtypes.
2. Sensitivity of benign breast tumor according to histology.
3. Feasibility of portable breast tumor detector.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1. Female older than 20 years old.
2. Patients with histologically confirmed breast cancer (only cohort 1).
3. Confirmed breast tumor by one or more arbitrary image examination; mammography, breast ultrasonography, contrast breast MRI and FDG-PET examination.
4. Signed informed consent.

Exclude criteria

1. History of chemotherapy or radiotherapy within 6 months before registration.
2. Hypersensitivity to ABS plastic resin.
3. Having a pacemaker.
4. Decision of the physician.

Related Information

• Primary Sponsor: Okada Morihito
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports, Science and Technology