Breast ReconstructionBESTNCT06779019
a Prospective Study of Surgical Results, Complications and Predictive Values in Chinese Women Breast Reconstruction
An observational study of Breast Reconstruction and Flap Necrosis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study prospectively evaluates and compares the effectiveness of ICG fluorescence imaging and LSCI in predicting the risk of necrosis following direct-to-implant breast reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Reconstruction, Flap Necrosis
- What is being tested?
- LSCI and ICG (Indocyanine Green)
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 1 Jul 2024
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: female patients who received mastectomy and immediate direct-to-implant reconstruction
Who may be able to join
- All patients presenting for implant-base reconstruction immediately after mastectomy
Who cannot join
- delayed reconstruction, expander removal followed by prothesis implant, ICG allergy or intolerance, autologous reconstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breast Enhanced Strategies and Techniques(BEST) (Focus on Chinese Breast Reconstruction) Trial PART 1: Evaluation of Predictive Methods of Reconstruction Outcomes--Flap Perfusion Analysis
This study prospectively evaluates and compares the effectiveness of ICG fluorescence imaging and LSCI in predicting the risk of necrosis following direct-to-implant breast reconstruction.
Read the detailed description
This study prospectively evaluates and compares the effectiveness of Indocyanine Green (ICG) fluorescence imaging and Laser Speckle Contrast Imaging (LSCI) in predicting the risk of necrosis following direct-to-implant breast reconstruction. The investigation includes both intraoperative and postoperative assessments of flap perfusion, with a focus on identifying specific thresholds for necrosis prediction. By analyzing the sensitivity, specificity, and predictive accuracy of each technique, the study aims to establish their respective strengths and limitations. Additionally, the research aims to explore the feasibility of using these methods in different surgical stages, evaluating their consistency and reliability in monitoring the viability of the skin flap and nipple-areolar complex.
- Conditions
- Breast Reconstruction, Flap Necrosis
- Being tested
- LSCI, ICG (Indocyanine Green)
- Keywords
- LSCI, ICG, breast reconstruction, implant-based breast reconstruction, flap necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSCIDiagnostic test
LSCI evaluates at 2 timings:immediately after the mastectomy (prior to immediate reconstruction) and again following reconstruction (after the skin was sutured). The perfusion score was calculated by normalizing these values against the perfusion value of a control.
ICG (Indocyanine Green)Diagnostic test
Performed immediately after the mastectomy (prior to immediate reconstruction) .Perfusion scores were determined by comparing the fluorescence intensity of the target area to that of the non-surgical region on the contralateral chest wall.
| Study group | Role | What they receive |
|---|---|---|
| patients underwent immediate direct-to-implant reconstruction | Patients undergoing nipple-sparing mastectomy (NSM) received flap evaluations for both the nipple-areolar complex (NAC) and the peri-incision skin flap. Perfusion of the skin flap and nipple was assessed using both Laser Speckle Contrast Imaging (LSCI) and Indocyanine Green (ICG) fluorescence imaging at two critical time points: immediately after the mastectomy (prior to immediate reconstruction) and again following reconstruction (after the skin was sutured). Receives: Diagnostic Test: LSCI; Diagnostic Test: ICG (Indocyanine Green) |
What is being measured
The primary outcome is the main question the study is designed to answer.
necrosis
Signs of necrosis included: (1) swelling or blistering, (2) dark brown or dark blue discoloration of the flap or nipple-areolar complex (NAC), (3) scab formation, (4) wound disruption, and (5) sloughing of the NAC or local flap. Severe necrosis was defined as either (4) or (5), necessitating debridement and secondary closure surgery.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study start1 Sep 2022
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical Board (CMB)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779019
- Sponsor's protocol ID
- ZS-3103
- Acronym
- BEST
- Status last verified
- Oct 2023
- First submitted
- 12 Jan 2025
- Last updated
- 16 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu R, Lan Y, Zhang H, Pan B, Du F, Zhou Y, Long X. Revolutionizing Precision of Necrosis: Laser Speckle Contrast Imaging versus Indocyanine Green for Breast Flap Viability. Plast Reconstr Surg. 2026 Aug 1;158(2):223-233. doi: 10.1097/PRS.0000000000012685. Epub 2026 Jul 28.
PubMed 42519935
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Enhanced Strategies and Techniques(BEST) (Focus on Chinese Breast Reconstruction) Trial PART 1: Evaluation of Predictive Methods of Reconstruction Outcomes--Flap Perfusion Analysis
- ClinicalTrials.gov ID
- NCT06779019
- Acronym / sponsor ID
- BEST / ZS-3103
- Conditions
- Breast Reconstruction, Flap Necrosis
- Keywords
- LSCI, ICG, breast reconstruction, implant-based breast reconstruction, flap necrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- China Medical Board (CMB)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 16 Jan 2025 (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.
This study prospectively evaluates and compares the effectiveness of ICG fluorescence imaging and LSCI in predicting the risk of necrosis following direct-to-implant breast reconstruction.
Detailed description
This study prospectively evaluates and compares the effectiveness of Indocyanine Green (ICG) fluorescence imaging and Laser Speckle Contrast Imaging (LSCI) in predicting the risk of necrosis following direct-to-implant breast reconstruction. The investigation includes both intraoperative and postoperative assessments of flap perfusion, with a focus on identifying specific thresholds for necrosis prediction. By analyzing the sensitivity, specificity, and predictive accuracy of each technique, the study aims to establish their respective strengths and limitations. Additionally, the research aims to explore the feasibility of using these methods in different surgical stages, evaluating their consistency and reliability in monitoring the viability of the skin flap and nipple-areolar complex.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients underwent immediate direct-to-implant reconstruction | – | Diagnostic Test: LSCI, Diagnostic Test: ICG (Indocyanine Green)Patients undergoing nipple-sparing mastectomy (NSM) received flap evaluations for both the nipple-areolar complex (NAC) and the peri-incision skin flap. Perfusion of the skin flap and nipple was assessed using both Laser Speckle Contrast Imaging (LSCI) and Indocyanine Green (ICG) fluorescence imaging at two critical time points: immediately after the mastectomy (prior to immediate reconstruction) and again following reconstruction (after the skin was sutured). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- female patients who received mastectomy and immediate direct-to-implant reconstruction
Key inclusion criteria (1 listed)
- All patients presenting for implant-base reconstruction immediately after mastectomy
Key exclusion criteria (1 listed)
- delayed reconstruction, expander removal followed by prothesis implant, ICG allergy or intolerance, autologous reconstruction
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 |
|---|---|---|
| LSCILSCI evaluates at 2 timings:immediately after the mastectomy (prior to immediate reconstruction) and again following reconstruction (after the skin was sutured). The perfusion score was calculated by normalizing these values against the perfusion value of a control. | Diagnostic test | patients underwent immediate direct-to-implant reconstruction |
| ICG (Indocyanine Green)Performed immediately after the mastectomy (prior to immediate reconstruction) .Perfusion scores were determined by comparing the fluorescence intensity of the target area to that of the non-surgical region on the contralateral chest wall. | Diagnostic test | patients underwent immediate direct-to-implant reconstruction |
Primary outcome
necrosis
Time frame: 3 months
Signs of necrosis included: (1) swelling or blistering, (2) dark brown or dark blue discoloration of the flap or nipple-areolar complex (NAC), (3) scab formation, (4) wound disruption, and (5) sloughing of the NAC or local flap. Severe necrosis was defined as either (4) or (5), necessitating debridement and secondary closure surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Derived from this study: PubMed 42519935Liu R, Lan Y, Zhang H, Pan B, Du F, Zhou Y, Long X. Revolutionizing Precision of Necrosis: Laser Speckle Contrast Imaging versus Indocyanine Green for Breast Flap Viability. Plast Reconstr Surg. 2026 Aug 1;158(2):223-233. doi: 10.1097/PRS.0000000000012685. Epub 2026 Jul 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Reconstruction and Flap Necrosis, run by Peking Union Medical College Hospital at 1 site in China.
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 1 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: finished, as of the sponsor's last update on 16 Jan 2025. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
necrosis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06779019, which also lists 1 linked publication.
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 16 Jan 2025.