Status:
COMPLETED
A Pilot Study of Ultrasound-guided Vacuum-assisted Excision of Breast Cancers
Lead Sponsor:
Manchester University NHS Foundation Trust
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
This study is looking into whether the procedure called Vacuum Assisted Excision (VAE) is a safe method for the removal of small and medium sized invasive breast cancers in patients who are unfit or h...
Eligibility Criteria
Inclusion
- The patient is aged 18 years or older.
- Diagnosis on core needle biopsy of invasive cancer of the breast
- Unifocal invasive tumour on imaging (hormone receptor positive or negative)
- T1 or T2 primary or locally recurrent tumour measuring ≤25mm on imaging, excluding any adjacent ductal carcinoma in situ (largest of the measurements on mammography (including digital breast tomosynthesis if performed) and ultrasound)
- The tumour is clearly visible on ultrasound
- Vacuum-assisted excision of the entire ultrasonically visible tumour is deemed to be technically feasible
- The patient is considered to be at high risk of complications or death from a general anaesthetic and therefore surgery under general anaesthesia is not considered appropriate. This must be confirmed by agreement by two named consultant breast surgeons, a multidisciplinary team meeting (including at least one consultant breast surgeon) or by formal anaesthetic assessment. Unsuitability for surgery under local anaesthetic must be confirmed by a consultant breast surgeon.
- or - The patient refuses to undergo surgery. This must be confirmed by a consultant surgeon and breast care nurse following full discussion of the treatment options.
- or - The patient is considered unlikely to benefit from surgical removal of the cancer by virtue of known metastatic disease or other life-shortening condition. This must be confirmed by discussion in a multidisciplinary team meeting which includes an oncologist.
- The patient has given written informed consent for the study Women who are already on primary endocrine therapy for a breast cancer and meet the inclusion criteria will also be eligible.
Exclusion
- The patient is on anticoagulants or has a known clotting disorder
- Pregnancy or lactation
- Allergy to local anaesthetic
Key Trial Info
Start Date :
June 25 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04679207
Start Date
June 25 2018
End Date
May 31 2021
Last Update
January 18 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M13 9WU