MR-guided vacuum assisted biopsy for MRI-only visible lesion.

MR-guided vacuum assisted biopsy for MRI-only visible lesion. - Breast Interventional Radiology Using MRI in Mie (BIRUMM-01)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004260

Enrollment

Registered

2010-10-18

Start date

2010-11-01

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

MRI-only visible lesion

Interventions

&lt

Study term&gt

1)Registration: from 11/01/2010 to 12/31/2012. 2)Follow-up: a year after registration. 3) Total: 3 years and 4 months. &lt

Protocol&gt

Target lesion is single every procedure. When multiple lesions are observed on one-side or both breast, target is decided by staff of current study. Both breast is not done every procedure. Each proce

s finger. A fiducial marker is placed around the expected site of the target lesion, and localizing sequences are acquired. Gd-DTPA 0.1 mmol/L per kg of body weight is administered rapidly through an

s stability. Imaging-histologic correlation is performed for all biopsy re

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Malignancy is highly suspected among MRI only visible lesions (we have diagnostic criteria). 2) Over twenty years-old. 3) Performance status is 0 to 2. 4) An informed consent was obtained from all patients after they had been provided with a detailed explanation about the procedure.

Exclusion criteria

Exclusion criteria: 1) Positive for HBs antigen or HCV antibody. 2) History of allergy for contrast medium (Gd-DTPA). 3) Serious heart disease or arrhythmia. 4) Serious liver dysfunction (AST or ALT over 100 IU/L) 5) Serious renal dysfunction (eGFR under 40 ml/min.) 6) During anti-coagulant therapy. 7) MRI examination is impossible (ex. installation of pacemaker, claustrophobia) 8) During or possible of pregnancy. 9) Staff decides inadequate case for current study.

Design outcomes

Primary

Measure	Time frame
Detection rate of breast cancer.	—

Secondary

Measure	Time frame
Hazardous phenomenon, Negative productive value, success rate of procedure, Pathologic type of obtained specimen, Surgical method (case of malignancy)	—

Countries

Japan

Contacts

Public ContactShigeki Kobayashi

Mie University Hospital Healthscience Center

koba@mri-gw.medic.mie-u.ac.jp059-232-1111

Outcome results

None listed

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