Minimal invasive breast cancer excision using vacuum assisted biopsy under ultrasound guidance

Minimal invasive breast cancer excision using vacuum assisted biopsy under ultrasound guidance - MINIVAB

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON52555

Enrollment

210

Registered

2020-02-11

Start date

2021-08-02

Completion date

Unknown

Last updated

2026-07-20

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

Conditions

breast cancer Carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Female sex. 2. 18 years or older. 3. US visible breast cancer. 4. Histologically proven non-lobular invasive breast carcinoma with maximum diameter of 15 mm as assessed by US. 5. Willing and able to undergo preoperative breast MRI 6. Able to fill out the questionnaire 7. Able to provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Male sex. 2. 17 years or younger. 3. No proven invasive breast cancer. 4. Poor US visibility of the breast cancer. 5. Neoadjuvant therapy. 6. Contra-indications to breast MRI or intravenous contrast administration. 7. Unable to fill out the questionnaire 8. Unable to provide informed consent. 9. Patients with breast implants. 10. Pregnancy. 11. Presence of ipsilateral lesions on MRI.

Design outcomes

Primary

Measure	Time frame
The main endpoint of this study is the frequency of successful complete tumour excision by the VAB, where successful is defined as *having tumour free margins, and no residual (in situ) cancer in the surgical specimen'.	—

Secondary

Measure	Time frame
- Whether we can predict successful complete resection of the tumor based on imaging features other than size. - Whether we can predict successful complete resection of the tumor based upon histopathological features from the large core biopsy specimens. - To analyze the characteristics of eventual residual tumor deposits in the surgical specimens. - To explore SN status following VAB of the primary tumor. - Analyze the difference in quality-of-life and pain experience between VAB excision and surgery.	—

Measure

Time frame

- Whether we can predict successful complete resection of the tumor based on imaging features other than size. - Whether we can predict successful complete resection of the tumor based upon histopathological features from the large core biopsy specimens. - To analyze the characteristics of eventual residual tumor deposits in the surgical specimens. - To explore SN status following VAB of the primary tumor. - Analyze the difference in quality-of-life and pain experience between VAB excision and surgery.

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Countries

Netherlands

Outcome results