Laser Speckle Imaging During Breast Reconstruction

NCT06523452 | Recruiting DMC

• 1 other identifier: 2405577
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Around 3500 women a year have surgery to reconstruct a breast/s after cancer. Breast reconstruction can have a positive impact on their lives, but unfortunately 3 or 4 in 10 women have problems with healing after their operation. This is distressing and often leads to more medical care or surgery. These problems are often caused by poor blood flow to the skin and deeper tissues used to reconstruct the breast. The investigators have developed a new device that does not touch the skin and provides immediate, continuous images of skin blood flow (the flow that surgeons cannot see). To test this device the investigators took images of blood flow during breast reconstruction surgery. The investigators found that imaging was good at showing where skin blood flow was poor and led to problems with healing and where flow was good and there were fewer problems after surgery (from minor problems, e.g. delayed healing; to major problems, e.g. loss of new breast). The investigators think this device can help surgeons choose healthy skin during breast reconstruction and so help more patients to heal without surgical problems. The investigators need to test the new imaging device in a large clinical trial to find out how effective it is at improving healing for women after breast reconstruction. Before this, the investigators need to find out if such a trial is possible and acceptable to patients, theatre staff and surgeons. The investigators will recruit 60 women who are having breast surgery and will randomly choose 30 to have surgery without blood flow imaging and 30 to have surgery with blood flow imaging. The investigators will follow up the women whilst in hospital and for the following 6 months to record any problems. In particular the investigators need to find out how many patients will volunteer for the study and the study can collect all the information needed during the 6 months after surgery. The results from this study will be used to plan a much larger clinical trial that will test whether blood flow imaging is effective, improves patient recovery after surgery and provides good value for money for the NHS.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Recruitment and retention rate for both LSI-Assisted and TAU groups

  Number of participants recruited to the study and number lost to follow up

  End of Trial - 6 months after entry of final participant

• Rates of post-operative complications for both LSI and TAU groups

  Number of participants with post-operative complications and their severity over 6 months post operative using patient diaries and patient notes assessed by Clavien-Dindo or CTCAE.

  End of Trial - 6 months after entry of final participant

Secondary Outcomes (4)

• A health economic framework for the future trial.

  End of Trial - 6 months after entry of final participant

• LSI training manual and understanding the views of theatre staff on the use of LSI.

  End of Trial - 6 months after entry of final participant

• Understanding the views of patients on the use of LSI.

  End of Trial - 6 months after entry of final participant

• LSI perfusion measures in the two groups

  End of Trial - 6 months after entry of final participant

Study Arms (2)

LSI Assisted Group

EXPERIMENTAL

Breast reconstruction surgery will be standard clinical care, but tissue blood flow images will be available during surgery to aid surgical decision making. The surgical procedure will take slightly longer (approximately 10-15 minutes in total) compared to the Treatment As Usual group.

Other: Laser Speckle Imaging

Treatment As Usual Group

NO INTERVENTION

Breast reconstruction surgery will be standard clinical care

Interventions

Laser Speckle Imaging OTHER

At least three scans (four for skin sparing mastectomy) will be performed on participants randomised to the LSI Assisted Group. Further scans may be taken at the discretion of the surgeon.

LSI Assisted Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, aged 18 or over;
• Able and willing to provide informed consent;
• Scheduled for breast reconstruction by autologous free flap surgery (either immediately post-mastectomy or delayed).

You may not qualify if:

• Unable to give written informed consent.

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead
• University of Exeter: collaborator

Study Sites (1)

Royal Devon University Healthcare NHS Foundation Trust

Exeter, Devon, EX2 5DW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Laser Speckle Contrast Imaging

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Lucy Gates, PhD

CONTACT

01392 408181; lucy.gates1@nhs.net

Angela Shore

CONTACT

01392 403091; a.c.shore@exeter.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: July 26, 2024
• Study Start: April 25, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: July 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)