Clinical trial NCT04679207: A Pilot Study of Ultrasound-guided Vacuum-assisted Excision of Breast Cancers
Official title: A Pilot Study of Ultrasound-guided Vacuum-assisted Excision of Breast Cancers (the PICASSO Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2020-12-22
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients who require a safe method for the removal of small and medium sized invasive breast cancers in patients who are unfit or have refused to have surgery to remove cancer.

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 have refused to have surgery to remove cancer.

Recruitment Target: 20


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* The patient is on anticoagulants or has a known clotting disorder
* Pregnancy or lactation
* Allergy to local anaesthetic

Primary outcomes:
measure: Greatest dimension of the Cancer
timeFrame: 1 year
Secondary outcomes:
measure: Recruitment Uptake
timeFrame: 12 months
measure: Procedure Times
timeFrame: 12 months
measure: Procedure pain and acceptability
timeFrame: 12 months
measure: Complication rate of VAE
timeFrame: 12 months
measure: Proportion of Cancer removed
timeFrame: 12 months
measure: Residual Cancer after VAE
timeFrame: 2 years post VAE
measure: Requirement of salvage surgery
timeFrame: 2 years post VAE
measure: Histopathology of cavity walls
timeFrame: Imaging at 1 year and 2 years.
measure: proportion willing to undergo the procedure again if necessary.
timeFrame: 12 months
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester University NHS Foundation Trust
Study officials:
References: