Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04679207
Recruitment Status : Recruiting
First Posted : December 22, 2020
Last Update Posted : November 2, 2021
Sponsor:
Information provided by (Responsible Party):
Manchester University NHS Foundation Trust

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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


Condition or disease Intervention/treatment
Breast Cancer Procedure: Vacuum-assisted excision

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study of Ultrasound-guided Vacuum-assisted Excision of Breast Cancers (the PICASSO Study)
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Procedure: Vacuum-assisted excision
    Vacuum-assisted biopsy (VAB) is a minimally invasive technique performed under local anaesthetic as an outpatient procedure by radiologists using x-ray or ultrasound guidance. It was developed in the USA in the mid 1990s and has become well established as a diagnostic test for suspected breast disease. It uses the combination of a large gauge biopsy needle and suction to allow larger pieces of tissue to be removed than can be obtained with a standard needle biopsy device. The technique is used widely for diagnostic purposes and, in some centres, for the therapeutic removal of benign breast lumps such as fibroadenomas and papillomas.

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Recruitment Uptake [ Time Frame: 12 months ]
    Proportion of eligible women offered the study who consent to participate.

  2. Procedure Times [ Time Frame: 12 months ]
    Time taken for each VAE procedure.

  3. Procedure pain and acceptability [ Time Frame: 12 months ]
    11-point numerical rating pain score - with 0 being no pain and 10 being worst pain imaginable

  4. Complication rate of VAE [ Time Frame: 12 months ]
    Proportion of women who have significant bleeding after the procedure (defined as bleeding requiring > 20 minutes manual compression to control and/or a haematoma requiring aspiration or surgical evacuation) or infection at the VAE site (defined as requiring antibiotic treatment and/or an abscess requiring aspiration or surgery).

  5. Proportion of Cancer removed [ Time Frame: 12 months ]
    Proportion of women in whom the cancer appears to be completely removed as judged on ultrasound at the end of the VAE procedure

  6. Residual Cancer after VAE [ Time Frame: 2 years post VAE ]
    Proportion of participants in whom the greatest dimension of the cancer on imaging at 2 years post-VAE is less ≤ 50% of its pre-VAE size.

  7. Requirement of salvage surgery [ Time Frame: 2 years post VAE ]
    Proportion of participants who undergo surgery to the ipsilateral breast within 2 years of the VAE procedure because of continued growth of the tumour.

  8. Histopathology of cavity walls [ Time Frame: Imaging at 1 year and 2 years. ]
    Proportion of participants with positive and negative cavity wall biopsies respectively who have tumour visible on imaging at 1 and 2 years.

  9. proportion willing to undergo the procedure again if necessary. [ Time Frame: 12 months ]
    proportion willing to undergo the procedure again if necessary based on yes or no question


Biospecimen Retention:   Samples Without DNA
Participant will be given the option to consent to donating any surplus tumour tissue for use in other ethically approved studies.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04679207


Contacts
Layout table for location contacts
Contact: Hayley Brooks 0161 291 2433 Hayley.Brooks@mft.nhs.uk

Locations
Layout table for location information
United Kingdom
Manchester University NHS Foundation Trust Recruiting
Manchester, United Kingdom, M13 9WU
Contact: Hayley Brooks       hayley.brooks@mft.nhs.uk   
Sponsors and Collaborators
Manchester University NHS Foundation Trust
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Manchester University NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04679207    
Other Study ID Numbers: B00157
First Posted: December 22, 2020    Key Record Dates
Last Update Posted: November 2, 2021
Last Verified: November 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases