An interventional study of Laser Speckle Imaging in Breast Cancer, sponsored by Royal Devon and Exeter NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-26.
Sponsored by Royal Devon and Exeter NHS Foundation Trust · Not applicable, Interventional, and Other
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 60 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Royal Devon and Exeter NHS Foundation Trust is the lead sponsor of 63 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Breast reconstruction surgery will be standard clinical care
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.
Recruitment and retention rate for both LSI-Assisted and TAU groups
Number of participants recruited to the study and number lost to follow up
Time frame: 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.
Time frame: End of Trial - 6 months after entry of final participant
A health economic framework for the future trial.
Economic evaluation methods will be developed and tested on the collection of resource use, cost and QoL outcome data assessed using Resource Use, EQ-5D-5L and BREAST Q questionnaires.
Time frame: 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.
Develop appropriate training material for use of LSI Device through conducting pre-operative observations, focus groups and post operative interviews with theatre staff to assess feasibility and acceptability of LSI.
Time frame: End of Trial - 6 months after entry of final participant
Understanding the views of patients on the use of LSI.
Conduct qualitative interviews with patients in both LSI and TAU groups
Time frame: End of Trial - 6 months after entry of final participant
LSI perfusion measures in the two groups
Assess the perfusion through the
Time frame: End of Trial - 6 months after entry of final participant
Plan to share: No
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Royal Devon and Exeter NHS Foundation Trust