Evaluation of breast mass diagnosis with breast light and mammography

Comparative study of breast mass evaluation by a new diagnostic method (Breast Light) and mammography in women over forty years

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090701002114N8

Enrollment

252

Registered

2021-01-13

Start date

2021-01-19

Completion date

Unknown

Last updated

2021-02-22

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

Conditions

Diagnosis and screening of breast mass. Breast screening

Interventions

Intervention 1: Intervention group: The first intervention group includes all people for whom the Brest Light diagnostic method is used to examine breast masses. Intervention 2: Intervention group: Th

Eligibility

Sex/Gender

Female

Age

40 Years to No maximum

Inclusion criteria

Inclusion criteria: Women aged 40 and over Women who are candidates for breast cancer screening

Exclusion criteria

Exclusion criteria: pregnancy Reluctance to perform the screening process by Brest Light

Design outcomes

Primary

Measure	Time frame
The true positive detection rate of the Brest Light device. Timepoint: When using the Brest Light device, and then with a subsequent examination by mammography. Method of measurement: By examining the number of people who are positive for the Brest Light screening test, and these people are diagnosed as really ill with a subsequent examination through mammography and biopsy.;The true negative detection rate of the Brest Light device. Timepoint: When using the Brest Light device, and then with a subsequent examination by mammography. Method of measurement: By examining the number of people who are negative for the Brest Light screening test, and these people are diagnosed as really health with a subsequent examination through mammography.;The false positive detection rate of the Brest Light device. Timepoint: When using the Brest Light device, and then with a subsequent examination by mammography. Method of measurement: By examining the number of people who are positive for the Brest Light screening test, if by the next check by mammography these people are healthy.;The false negative detection rate of the Brest Light device. Timepoint: When using the Brest Light device, and then with a subsequent examination by mammography. Method of measurement: By examining the number of people who are negative for the Brest Light screening test, if by the next check by mammography these people are ill.	—

Measure

Time frame

The true positive detection rate of the Brest Light device. Timepoint: When using the Brest Light device, and then with a subsequent examination by mammography. Method of measurement: By examining the number of people who are positive for the Brest Light screening test, and these people are diagnosed as really ill with a subsequent examination through mammography and biopsy.;The true negative detection rate of the Brest Light device. Timepoint: When using the Brest Light device, and then with a subsequent examination by mammography. Method of measurement: By examining the number of people who are negative for the Brest Light screening test, and these people are diagnosed as really health with a subsequent examination through mammography.;The false positive detection rate of the Brest Light device. Timepoint: When using the Brest Light device, and then with a subsequent examination by mammography. Method of measurement: By examining the number of people who are positive for the Brest Light screening test, if by the next check by mammography these people are healthy.;The false negative detection rate of the Brest Light device. Timepoint: When using the Brest Light device, and then with a subsequent examination by mammography. Method of measurement: By examining the number of people who are negative for the Brest Light screening test, if by the next check by mammography these people are ill.

—

Secondary

Measure	Time frame
Brest Light diagnostic sensitivity. Timepoint: When using the Brest Light device, and then with a subsequent examination by mammography. Method of measurement: Divide the number of people who have a positive diagnostic test and are really sick by the number of people who have a positive screening result.;Brest Light diagnostic specificity. Timepoint: When using the Brest Light device, and then with a subsequent examination by mammography. Method of measurement: Divide the number of people who have a negative diagnostic test and are really healthy by the number of people who have a negative screening result.	—

Measure

Time frame

Brest Light diagnostic sensitivity. Timepoint: When using the Brest Light device, and then with a subsequent examination by mammography. Method of measurement: Divide the number of people who have a positive diagnostic test and are really sick by the number of people who have a positive screening result.;Brest Light diagnostic specificity. Timepoint: When using the Brest Light device, and then with a subsequent examination by mammography. Method of measurement: Divide the number of people who have a negative diagnostic test and are really healthy by the number of people who have a negative screening result.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Yari

Khoram-Abad University of Medical Sciences

yari.f@lums.ac.ir+98 66 3312 0133

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026