Clinical trial · Observational
A Pilot Study of Ultrasound-guided Vacuum-assisted Excision of Breast Cancers
A Pilot Study of Ultrasound-guided Vacuum-assisted Excision of Breast Cancers (the PICASSO Study)
NCT04679207CI-TRIAL-00063283PICASSOcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vacuum-assisted excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Greatest dimension of the Cancer
- timeFrame
- 1 year
- description
- 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 (9)
- measure
- Recruitment Uptake
- timeFrame
- 12 months
- description
- Proportion of eligible women offered the study who consent to participate.
- measure
- Procedure Times
- timeFrame
- 12 months
- description
- Time taken for each VAE procedure.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.