Clinical trial of electrical biopsy-free cancer diagnostic needle

Clinical trial of using standard spinal cannula for differentiation of benign and malignant lesions under sonography guidance to maximize accuracy of BIRADS scoring and CNB, based on electrical impedance spectroscopy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190904044697N4

Enrollment

100

Registered

2020-03-30

Start date

2020-06-21

Completion date

Unknown

Last updated

2020-04-21

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

Conditions

Condition 1: Malignant neoplasm of breast. Condition 2: Benign tumor with solid mass. Malignant neoplasm of breast Benign neoplasm of breast

Interventions

Intervention 1: Intervention group: Our surgical and radiological colleagues select some patients with solid tumors that are candidates of CNB or routine screening sonography for applying BFCDN based

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The population of patients visited by our surgical colleague that have solid tumors or previous diagnoses of breast cancer recommend for CNB The population of patients undergoing CNB by our radiological colleagues The population of patients undergoing screening sonography with suspicious lesions The population of patients undergoing screening sonography with a family background of breast cancer

Exclusion criteria

Exclusion criteria: The population of patients undergoing screening sonography without any suspicious lesion or a family background of breast cancer

Design outcomes

Primary

Measure	Time frame
The pathologic classification of breast lesions and the diagnosis of a benign or malignant mass are determined by electrical impedance analysis of the lesions. Results show meaningful consistency between DIN (Ductal Intraepithelial Neoplasia) based pathological diagnosis and BFCDN scoring. In addition to an auxiliary diagnostic method by BFCDN, H&E and IHC assays of samples of patients are accurately investigated by several pathologists and radiologists that increases the accuracy of diagnosis and also future treatments. In "probably benign" lesions(BI-RADS3) that patients are recommended by radiologist to short-interval follow ups, this protocol may lead to early detection of pre-cancerous lesions. Also in Bi-RADS4a lesions, it may lead to elimination of unnecessary core needle biopsies. Timepoint: Three days after intervention the results are compared with the results of permanent pathology. Method of measurement: Electrical Impedance Spectroscopy.	—

Measure

Time frame

The pathologic classification of breast lesions and the diagnosis of a benign or malignant mass are determined by electrical impedance analysis of the lesions. Results show meaningful consistency between DIN (Ductal Intraepithelial Neoplasia) based pathological diagnosis and BFCDN scoring. In addition to an auxiliary diagnostic method by BFCDN, H&E and IHC assays of samples of patients are accurately investigated by several pathologists and radiologists that increases the accuracy of diagnosis and also future treatments. In "probably benign" lesions(BI-RADS3) that patients are recommended by radiologist to short-interval follow ups, this protocol may lead to early detection of pre-cancerous lesions. Also in Bi-RADS4a lesions, it may lead to elimination of unnecessary core needle biopsies. Timepoint: Three days after intervention the results are compared with the results of permanent pathology. Method of measurement: Electrical Impedance Spectroscopy.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Abdolahad

Tehran University of Medical Sciences

m.abdolahad@ut.ac.ir+98 21 8802 8367

Outcome results

None listed

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