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Efficacy and safety of MRI guided vacuum assisted biopsy for MRI only visible lesion

Efficacy and safety of MRI guided vacuum assisted biopsy for MRI only visible lesion - Efficacy and safety of MRI guided vacuum assisted biopsy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000012547
Enrollment
44
Registered
2013-12-12
Start date
2013-12-05
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

All patients are performed MRI guided vacuum assisted biopsy for MRI only visible breast lesion. After the patient receives skin anesthesia, the needle path is cut by a precutter according to these

Sponsors

Hiroshima University Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) 1:malignancy is highly suspected lesion (over category 4 BIRADS-MRI) among MRI only visible lesions. 2:Biopsy is highly recommended lesion (over category 3 BIRADS-MRI)among MRI only visible lesions of which those have BRCA1 /2 mutation 2) Over twenty yeares-old. 3) Performance status is 0 to2. 4) An informed conscent was obtained from all patients after they had been provided with a detailed explanation about the procedure.

Exclusion criteria

Exclusion criteria: 1)History of allergy for contrast medium (Gd-DTPA) 2) The lesion is too close to perform the procedure. 3) Serious heart disease or arrithmia. 4) Serious liver dysfunction 5) Serious renal dysfunction 6) During anti-coagulation 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

MeasureTime frame
Detection rate of breast cancer.

Secondary

MeasureTime frame
Hazardous phenomenon Negative productive value success rate of procedure Pathological type

Countries

Japan

Contacts

Public ContactKeiko Kajitani

Hiroshima University Hospital Breast Surgery

kajitanikeiko0226@yahoo.co.jp082-257-5869

Outcome results

None listed

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