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Diagnostic accuracy of portable breast tumor detector

Diagnostic accuracy of portable breast tumor detector for breast tumor - PORBRATOR-2

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs062180005
Enrollment
120
Registered
2018-11-07
Start date
2018-11-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer, Benign breast tumor

Interventions

Measurement of bilateral breast using study device

Sponsors

Okada Morihito
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of breast cancer and benign breast tumor by portable breast tumor detector.

Secondary

MeasureTime frame
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.

Contacts

Public ContactShinsuke Sasada

Hiroshima University Hospital

shsasada@hiroshima-u.ac.jp+81-82-257-5869

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026