Skip to main content
MedPathMedPath Home
Clinical Trials/NCT04679207
NCT04679207
Completed
Not Applicable

A Pilot Study of Ultrasound-guided Vacuum-assisted Excision of Breast Cancers (the PICASSO Study)

Manchester University NHS Foundation Trust1 site in 1 country7 target enrollmentStarted: June 25, 2018Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Status
Completed
Enrollment
7
Locations
1
Primary Endpoint
Greatest dimension of the Cancer
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Greatest dimension of the Cancer

Time Frame: 1 year

The proportion of participants in whom the greatest dimension of the cancer on imaging at 1 year post-vacuum assisted excision (VAE) is ≤50% of its pre-VAE size.

Secondary Outcomes

  • Complication rate of VAE(12 months)
  • Recruitment Uptake(12 months)
  • Procedure Times(12 months)
  • Proportion of Cancer removed(12 months)
  • Procedure pain and acceptability(12 months)
  • proportion willing to undergo the procedure again if necessary.(12 months)
  • Requirement of salvage surgery(2 years post VAE)
  • Residual Cancer after VAE(2 years post VAE)
  • Histopathology of cavity walls(Imaging at 1 year and 2 years.)

Investigators

Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Recruiting
Not Applicable
Excisional Vacuum-Assisted Breast BiopsyAtypical Ductal HyperplasiaDuctal Carcinoma in Situ
NCT05932758European Institute of Oncology300
Recruiting
Not Applicable
Vacuum Excision: percutaneous minimaly invasive diagnosis and tretament of Early Breast Cancer at oncenilateral Breast Neoplasms.C50.9
RBR-85nxvjdFaculdades Integradas Pitágoras de Montes Claros
Withdrawn
Not Applicable
Comparing Vacuum-Assisted Percutaneous Excision to Open Surgical Excision for Borderline or High-Risk Breast LesionsBreast FibroadenomaAtypical Ductal HyperplasiaAtypical Lobular HyperplasiaLobular Carcinoma in SituFlat Epithelial AtypiaPhyllodes; FibroadenomaPhyllodes Breast TumorRadial ScarBreast PapillomaComplex Sclerosing Papillary Lesion of the Breast
NCT03868475London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's90
Recruiting
Not Applicable
Ultrasound Ablation for Essential Hypertension（FIM）Uncontrolled Essential Hypertension
NCT05795829Lepu Medical Technology (Beijing) Co., Ltd.10
Unknown
Not Applicable
High Intensity Focused Ultrasound in PAtients With Varicose Veins in SingaporeVaricose VeinsVenous RefluxChronic Venous Insufficiency
NCT04339088Singapore General Hospital15