Breast CancerSIMBARNCT06523452
Laser Speckle Imaging During Breast Reconstruction
A study testing Laser Speckle Imaging in people with Breast Cancer, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Laser Speckle Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Apr 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Unable to give written informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Devon University Healthcare NHS Foundation Trust
Exeter, Devon, EX2 5DW
Lucy Gates, 01392 408181, lucy.gates1@nhs.net
Angela Shore, 01392403091, a.c.shore@exeter.ac.uk
About this study
Official title: The Clinical and Cost Effectiveness of Intra-operative Laser Speckle Imaging (LSI) of Tissue Blood Flow to Avoid Post-operative Complications Following Breast Reconstruction After Mastectomy for Breast Cancer: A Feasibility Study
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
- Being tested
- Laser Speckle Imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Speckle ImagingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Laser Speckle Imaging |
| Treatment As Usual Group | No intervention | Breast reconstruction surgery will be standard clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment and retention rate for both LSI-Assisted and TAU groups
Number of participants recruited to the study and number lost to follow up
Measured: 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.
Measured: End of Trial - 6 months after entry of final participant
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: End of Trial - 6 months after entry of final participant
LSI perfusion measures in the two groups
Assess the perfusion through the
Measured: End of Trial - 6 months after entry of final participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start25 Apr 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Exeter
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523452
- Sponsor's protocol ID
- 2405577
- Acronym
- SIMBAR
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical and Cost Effectiveness of Intra-operative Laser Speckle Imaging (LSI) of Tissue Blood Flow to Avoid Post-operative Complications Following Breast Reconstruction After Mastectomy for Breast Cancer: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06523452
- Acronym / sponsor ID
- SIMBAR / 2405577
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Exeter
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LSI Assisted Group | Experimental | Other: Laser Speckle ImagingBreast 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. |
| Treatment As Usual Group | No intervention | –Breast reconstruction surgery will be standard clinical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- Unable to give written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser Speckle ImagingAt 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. | Other | LSI Assisted Group |
Primary outcome
Recruitment and retention rate for both LSI-Assisted and TAU groups
Time frame: End of Trial - 6 months after entry of final participant
Number of participants recruited to the study and number lost to follow up
Rates of post-operative complications for both LSI and TAU groups
Time frame: End of Trial - 6 months after entry of final participant
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.
4 secondary outcomes
A health economic framework for the future trial.
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.
Time frame: End of Trial - 6 months after entry of final participant
Understanding the views of patients on the use of LSI.
Time frame: End of Trial - 6 months after entry of final participant
LSI perfusion measures in the two groups
Time frame: End of Trial - 6 months after entry of final participant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Speckle Imaging in people with Breast Cancer, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucy Gates, PhD (01392 408181, lucy.gates1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and retention rate for both LSI-Assisted and TAU groups (time frame: End of Trial - 6 months after entry of final participant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.