Breast CancersNCT06956443
Prediction of ICG for Skin Necrosis in Mastectomy With Immediate Reconstruction
An observational study of Breast Cancers and Mastectomy and Breast Reconstruction, run by University Medical Center Groningen.
Trial summary
Background Breast cancer represents 30 percent of newly diagnosed malignancies in female patients and is the leading cause of death in middle-aged women. Surgical treatment of breast cancer is performed with breast-conserving surgery or mastectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancers, Mastectomy and Breast Reconstruction, Skin Necrosis
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing mastectomy with immediate reconstruction using ICG-NIR (as standard care) will be included if they meet the inclusion criteria. The treating surgeon will screen the patients and ask for their consent to use their data.
Who may be able to join
- Age >18 years
- Patients undergoing mastectomy with immediate reconstruction using ICG-NIR
- Patients are mentally competent
- Written informed consent
Who cannot join
- Patients with known allergy to ICG or iodinated contrast media
- Pregnant or lactating women
- Patients with dialysis-dependent renal failure and renal transplantation
About this study
Official title: The Predictive Value of Quantified Indocyanine Green Fluorescent Angiography for Skin Necrosis in Mastectomy With Immediate Reconstruction
Background Breast cancer represents 30 percent of newly diagnosed malignancies in female patients and is the leading cause of death in middle-aged women. Surgical treatment of breast cancer is performed with breast-conserving surgery or mastectomy. An increasing proportion of breast cancer patients undergo breast reconstruction after mastectomy. Reconstruction can be performed using various techniques that may involve the use of autologous tissues, implants, or a combination of both. However, mastectomy followed by immediate reconstruction can be associated with complications, including skin and fat necrosis, which occurs in 20% of cases.
When assessing tissue perfusion during immediate reconstruction, the surgeon relies on subjective observations, including skin color, capillary refill, and the occurrence of bleeding. One possible technique to assist the surgeon in assessing tissue perfusion is near-infrared (NIR) fluorescence imaging with Indocyanine Green (ICG). ICG can visualize tissue perfusion, because once in the bloodstream it is completely and permanently fixed to plasma proteins and circulates only in the intravascular compartment. ICG was approved for clinical use of tissue perfusion as early as 1956, such as in intestinal anastomoses, for the perfusion of free flaps or parathyroid glands.
Read more
ICG can also help predict postoperative skin necrosis in breast reconstruction after mastectomy. In patients undergoing (reconstructive) breast surgery, the intraoperative use of ICG NIR fluorescence imaging has been shown to help surgeons assess skin viability, thereby reducing the occurrence of skin necrosis in several studies. This reduction in necrosis can be explained by the intraoperative removal of tissue with reduced fluorescence intensity, observed with ICG NIR fluorescence imaging. However, there is no consensus on which ICG-NIR perfusion parameter is most accurate for assessing tissue perfusion. Further research is needed to determine cut-off values for adequate tissue perfusion. This study focuses on quantifying perfusion parameters and determining the diagnostic accuracy of ICG-NIR in patients undergoing mastectomy with immediate reconstruction.
What is the purpose of the study/research question? The purpose of this study is to determine the predictive value of quantified ICG fluorescence angiography for the occurrence of skin necrosis in patients undergoing mastectomy with immediate reconstruction with associated cut-off values.
Study design/procedure and intervention:
This will be a prospective cohort study of patients undergoing mastectomy with immediate reconstruction using ICG-NIR (the use of ICG during these operations is not an additional procedure).
This study will include patients who have undergone surgery with ICG (mastectomy with immediate reconstruction). We will use the videos of the ICG angiography for quantitative analysis of the data. This data will be correlated with the postoperative outcome (occurrence of skin/fat necrosis).
All patients will be asked in advance for permission to use their data. This will be processed pseudo-anonymously.
- Keywords
- ICG, mastectomy, breast cancer, breast reconstruction, skin necrosis
- Medical subject headings
- Breast Neoplasms, Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ICG group | All patients (those undergoing mastectomy with immediate breast reconstruction) belong to the same cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between occurrence of postoperative skin necrosis and quantified perfusion parameters
The occurrence of postoperative skin necrosis, defined as clinically evident necrosis of the mastectomy skin flap or subcutaneous fat, within the postoperative period.
This will be correlated with quantified perfusion parameters obtained from intraoperative ICG-NIR fluorescence angiography, with the aim of determining the predictive value of these parameters.
Measured: From enrollment to the end of analysis at 1 year and a half
Secondary outcomes (2)
Diagnostic accuracy
Diagnostic accuracy of ICG-NIR fluorescence angiography in predicting postoperative skin necrosis, assessed by:
Sensitivity
Specificity
Positive and negative predictive values
Area under the receiver operating characteristic (ROC) curve (AUC)
Measured: From enrollment to the end of analysis at 1 year and a half
Optimal cut-off values
Determination of optimal cut-off values for key ICG-NIR perfusion parameters (e.g., maximum fluorescence intensity, slope, time-to-peak, perfusion index), using ROC analysis, to differentiate between adequately and inadequately perfused tissue. The optimal cut-off values for perfusion parameters will be identified using Youden's index.
Measured: From enrollment to the end of analysis at 1 year and a half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancersStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- Martini Hospital Groningen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956443
- Sponsor's protocol ID
- nr. 2025-015
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Quantified Indocyanine Green Fluorescent Angiography for Skin Necrosis in Mastectomy With Immediate Reconstruction
- ClinicalTrials.gov ID
- NCT06956443
- Acronym / sponsor ID
- nr. 2025-015
- Keywords
- ICG, mastectomy, breast cancer, breast reconstruction, skin necrosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- Martini Hospital Groningen
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 4 May 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.
Background Breast cancer represents 30 percent of newly diagnosed malignancies in female patients and is the leading cause of death in middle-aged women. Surgical treatment of breast cancer is performed with breast-conserving surgery or mastectomy. An increasing proportion of breast cancer patients undergo breast reconstruction after mastectomy. Reconstruction can be performed using various techniques that may involve the use of autologous tissues, implants, or a combination of both. However, mastectomy followed by immediate reconstruction can be associated with complications, including skin and fat necrosis, which occurs in 20% of cases.
When assessing tissue perfusion during immediate reconstruction, the surgeon relies on subjective observations, including skin color, capillary refill, and the occurrence of bleeding. One possible technique to assist the surgeon in assessing tissue perfusion is near-infrared (NIR) fluorescence imaging with Indocyanine Green (ICG). ICG can visualize tissue perfusion, because once in the bloodstream it is completely and permanently fixed to plasma proteins and circulates only in the intravascular compartment. ICG was approved for clinical use of tissue perfusion as early as 1956, such as in intestinal anastomoses, for the perfusion of free flaps or parathyroid glands.
ICG can also help predict postoperative skin necrosis in breast reconstruction after mastectomy. In patients undergoing (reconstructive) breast surgery, the intraoperative use of ICG NIR fluorescence imaging has been shown to help surgeons assess skin viability, thereby reducing the occurrence of skin necrosis in several studies. This reduction in necrosis can be explained by the intraoperative removal of tissue with reduced fluorescence intensity, observed with ICG NIR fluorescence imaging. However, there is no consensus on which ICG-NIR perfusion parameter is most accurate for assessing tissue perfusion. Further research is needed to determine cut-off values for adequate tissue perfusion. This study focuses on quantifying perfusion parameters and determining the diagnostic accuracy of ICG-NIR in patients undergoing mastectomy with immediate reconstruction.
What is the purpose of the study/research question? The purpose of this study is to determine the predictive value of quantified ICG fluorescence angiography for the occurrence of skin necrosis in patients undergoing mastectomy with immediate reconstruction with associated cut-off values.
Study design/procedure and intervention:
This will be a prospective cohort study of patients undergoing mastectomy with immediate reconstruction using ICG-NIR (the use of ICG during these operations is not an additional procedure).
This study will include patients who have undergone surgery with ICG (mastectomy with immediate reconstruction). We will use the videos of the ICG angiography for quantitative analysis of the data. This data will be correlated with the postoperative outcome (occurrence of skin/fat necrosis).
All patients will be asked in advance for permission to use their data. This will be processed pseudo-anonymously.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICG group | – | –All patients (those undergoing mastectomy with immediate breast reconstruction) belong to the same cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing mastectomy with immediate reconstruction using ICG-NIR (as standard care) will be included if they meet the inclusion criteria. The treating surgeon will screen the patients and ask for their consent to use their data.
Key inclusion criteria (4 listed)
- Age >18 years
- Patients undergoing mastectomy with immediate reconstruction using ICG-NIR
- Patients are mentally competent
- Written informed consent
Key exclusion criteria (3 listed)
- Patients with known allergy to ICG or iodinated contrast media
- Pregnant or lactating women
- Patients with dialysis-dependent renal failure and renal transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between occurrence of postoperative skin necrosis and quantified perfusion parameters
Time frame: From enrollment to the end of analysis at 1 year and a half
The occurrence of postoperative skin necrosis, defined as clinically evident necrosis of the mastectomy skin flap or subcutaneous fat, within the postoperative period. This will be correlated with quantified perfusion parameters obtained from intraoperative ICG-NIR fluorescence angiography, with the aim of determining the predictive value of these parameters.
2 secondary outcomes
Diagnostic accuracy
Time frame: From enrollment to the end of analysis at 1 year and a half
Optimal cut-off values
Time frame: From enrollment to the end of analysis at 1 year and a half
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancers and Mastectomy and Breast Reconstruction, run by University Medical Center Groningen.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Correlation between occurrence of postoperative skin necrosis and quantified perfusion parameters (time frame: From enrollment to the end of analysis at 1 year and a half). 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 4 May 2025.