NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs062180005

Registered date:07/11/2018

Diagnostic accuracy of portable breast tumor detector

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedBreast cancer, Benign breast tumor
Date of first enrollment26/11/2018
Target sample size120
Countries of recruitment
Study typeInterventional
Intervention(s)Measurement of bilateral breast using study device

Outcome(s)

Primary OutcomeSensitivity and specificity of breast cancer and benign breast tumor by portable breast tumor detector.
Secondary Outcome1.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 maximumNot applicable
GenderFemale
Include criteria1. 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 criteria1. 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

Contact

Public contact
Name Shinsuke Sasada
Address 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, Japan Hiroshima Japan 734-8551
Telephone +81-82-257-5869
E-mail shsasada@hiroshima-u.ac.jp
Affiliation Hiroshima University Hospital
Scientific contact
Name Morihito Okada
Address 1-2-3 Kasumi, Minami-ku, Hiroshima, 734-8551, Japan Hiroshima Japan 734-8551
Telephone +81-82-257-5869
E-mail morihito1217@gmail.com
Affiliation Research institute for radiation biology and medicine, Hiroshima university