Breast CancerNCT05623280
Artificial Intelligence Analysis of Fluorescence Image to Intraoperatively Detect Metastatic Sentinel Lymph Node.
An observational study of Breast Cancer and Sentinel Lymph Node, run by Xiang'an Hospital of Xiamen University at 1 site in China.
Trial summary
The purpose of this study is to analysis the fluorescence image of the breast sentinel lymph node (SLN) using Indocyanine green (ICG). Moreover, to investigate whether an artificial intelligence protocol was suitable for identifying metastatic status of SLN during the surgery, and evaluate the diagnosis consistency of… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Sentinel Lymph Node
- What is being tested?
- Indocyanine green
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 1 Dec 2024
- 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: Participants were recruited from Xiang'An Hospital of Xiamen University, between November 30, 2022, and November 30, 2024.
Who may be able to join
- Patients aged 18-70 years female.
- The preoperative core needle biopsy or open surgical excision biopsy diagnosis as breast cancer.
- No clinical examination of suspicious axillary lymph node-positive.
- Preoperative clinical or radiologic evidence without distant metastases (M0).
- The patient has good compliance with the planned protocol during the study and signed informed consent.
Who cannot join
- Pregnancy, breastfeeding.
- Allergy to ICG.
- Former operation or radiotherapy in the axilla or breast or thoracic wall in the same side of breast cancer.
- Psychiatric or cognitive impairment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiamen Key Laboratory of Endocrine-Related Cancer Precision Medicine
Xiamen, Fujian, 361000
Xueqi Fan, MD, 19859202604, fanxq@stu.xmu.edu.cn
About this study
Official title: Artificial Intelligence Analysis of Fluorescence Image to Intraoperatively Detect Metastatic Sentinel Lymph Node in Patients With Breast Cancer.
The purpose of this study is to analysis the fluorescence image of the breast sentinel lymph node (SLN) using Indocyanine green (ICG). Moreover, to investigate whether an artificial intelligence protocol was suitable for identifying metastatic status of SLN during the surgery, and evaluate the diagnosis consistency of the AI technique and pathological examinations for lymph node with and without metastasis.
Read the detailed description
Assessment of the sentinel lymph node (SLN) in patients with early stage breast cancer is vital in selecting the appropriate surgical approach. But identification of metastatic LNs within the fibro-adipose tissue of the fossa axillaris specimen remains a challenge. Recently, indocyanine green (ICG) and methylene blue are commonly used in clinical practice. ICG as a fluorescent dyes, has effectiveness in mapping SLNs during surgery. Surgeons can follow the fluorescence display to detect SLN, and simultaneously capture real-time fluorescent video images. Several other groups has been demonstrated that the usage of ICG fluorescent surgical navigation system to detect SLNs in breast cancer patients is technically feasible. But no study investigate the variability between fluorescent images of breast sentinel lymph node with and without metastasis in the existing paper. Deep learning (DL) artificial intelligence (AI) algorithms in medical imaging are rapidly expanding.
In this study, the investigators aim to develop and validate an easy-to-use artificial intelligence prediction model to intraoperatively identify the sentinel lymph node metastasis status. Furthermore, to explore whether this independent and parallel intraoperative lymph node assessment workflow can provide rapid and accurate skull base on lymph node fluorescent images analysis, meanwhile detecting occult lymph node (micro-) metastasis, using optical imaging and artificial intelligence.
- Conditions
- Breast Cancer, Sentinel Lymph Node
- Being tested
- Indocyanine green
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine greenDrug
Also called ICG
Injection around the areola with 2-4 points Indocyanine green with 2ml of 1.25mg/mL
| Study group | Role | What they receive |
|---|---|---|
| Indocyanine green | Injection around the areola with 2-4 points Indocyanine green with 2ml of 1.25mg/mL; Achieve Intraoperative fluorescence images by Near-Infrared I ( NIR-I ) fluorescence imaging instrument. Receives: Drug: Indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of lymph node metastasis
The lymph node metastasis (LNM) status was determined based on the pathological diagnosis of the surgical specimens.
Measured: Participants will be followed for the duration of hospital stay, an expected average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start1 Nov 2021
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiang'an Hospital of Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xueqi Fan, MD, Principal investigator, School of Medicine, Xiamen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623280
- Sponsor's protocol ID
- Xiang'an Hospital of XMU
- Status last verified
- Nov 2022
- First submitted
- 13 Nov 2022
- Last updated
- 28 Nov 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Analysis of Fluorescence Image to Intraoperatively Detect Metastatic Sentinel Lymph Node in Patients With Breast Cancer.
- ClinicalTrials.gov ID
- NCT05623280
- Acronym / sponsor ID
- Xiang'an Hospital of XMU
- Conditions
- Breast Cancer, Sentinel Lymph Node
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xiang'an Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 21 Nov 2022 (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.
The purpose of this study is to analysis the fluorescence image of the breast sentinel lymph node (SLN) using Indocyanine green (ICG). Moreover, to investigate whether an artificial intelligence protocol was suitable for identifying metastatic status of SLN during the surgery, and evaluate the diagnosis consistency of the AI technique and pathological examinations for lymph node with and without metastasis.
Detailed description
Assessment of the sentinel lymph node (SLN) in patients with early stage breast cancer is vital in selecting the appropriate surgical approach. But identification of metastatic LNs within the fibro-adipose tissue of the fossa axillaris specimen remains a challenge. Recently, indocyanine green (ICG) and methylene blue are commonly used in clinical practice. ICG as a fluorescent dyes, has effectiveness in mapping SLNs during surgery. Surgeons can follow the fluorescence display to detect SLN, and simultaneously capture real-time fluorescent video images. Several other groups has been demonstrated that the usage of ICG fluorescent surgical navigation system to detect SLNs in breast cancer patients is technically feasible. But no study investigate the variability between fluorescent images of breast sentinel lymph node with and without metastasis in the existing paper. Deep learning (DL) artificial intelligence (AI) algorithms in medical imaging are rapidly expanding.
In this study, the investigators aim to develop and validate an easy-to-use artificial intelligence prediction model to intraoperatively identify the sentinel lymph node metastasis status. Furthermore, to explore whether this independent and parallel intraoperative lymph node assessment workflow can provide rapid and accurate skull base on lymph node fluorescent images analysis, meanwhile detecting occult lymph node (micro-) metastasis, using optical imaging and artificial intelligence.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indocyanine green | – | Drug: Indocyanine greenInjection around the areola with 2-4 points Indocyanine green with 2ml of 1.25mg/mL; Achieve Intraoperative fluorescence images by Near-Infrared I ( NIR-I ) fluorescence imaging instrument. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants were recruited from Xiang'An Hospital of Xiamen University, between November 30, 2022, and November 30, 2024.
Key inclusion criteria (5 listed)
- Patients aged 18-70 years female.
- The preoperative core needle biopsy or open surgical excision biopsy diagnosis as breast cancer.
- No clinical examination of suspicious axillary lymph node-positive.
- Preoperative clinical or radiologic evidence without distant metastases (M0).
- The patient has good compliance with the planned protocol during the study and signed informed consent.
Key exclusion criteria (4 listed)
- Pregnancy, breastfeeding.
- Allergy to ICG.
- Former operation or radiotherapy in the axilla or breast or thoracic wall in the same side of breast cancer.
- Psychiatric or cognitive impairment.
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 |
|---|---|---|
| Indocyanine greenAlso: ICGInjection around the areola with 2-4 points Indocyanine green with 2ml of 1.25mg/mL | Drug | Indocyanine green |
Primary outcome
Diagnosis of lymph node metastasis
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 months
The lymph node metastasis (LNM) status was determined based on the pathological diagnosis of the surgical specimens.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Xueqi Fan, MD principal investigator
School of Medicine, Xiamen University
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 Cancer and Sentinel Lymph Node, run by Xiang'an Hospital of Xiamen University 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 5 inclusion and 4 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 28 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xueqi Fan, MD (19859202604, fanxq@stu.xmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of lymph node metastasis (time frame: Participants will be followed for the duration of hospital stay, an expected average of 3 months). 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 28 Nov 2022.