Breast CancerNIR-IINCT06713161
Tumor-Targeted-NIR-II Fluorescent Molecular Probes for the Identification of Breast Cancer Tissue and SLN Metastatic Status
An observational study of Breast Cancer and Sentinel Lymph Node, run by Yunnan Cancer Hospital at 1 site in China.
Trial summary
Accurate evaluation of tumor boundaries in breast-conserving surgery is closely associated with reducing the second operation of patients. Meanwhile, accurately assessing sentinel lymph node (SLN) metastasis is crucial for determining the extent of axillary lymph node dissection (ALND) and minimizing complications. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, Sentinel Lymph Node, Metastases
- What is being tested?
- NIR-II Probe(i.e ICG-POL6326) incubation solution
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 25 Dec 2025
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The investigators plan to enroll 40 female patients, aged 18 to 75 years, who have been assessed to have resectable breast nodules or masses and are scheduled to undergo surgery. During the surgery, the resected tumors and lymph nodes will be incubated with theNIR-II probe(ICG-POL6326) solution, and NIR-II fluorescence signals from the tissues will be collected.
Who may be able to join
- Adult patients between 18-75 years of age
- Female
- Patients presenting with a breast nodule or mass presumed to be resectable on pre-operative assessment
- Good operative candidate
- Subject capable of giving informed consent and participating in the process of consent
Who cannot join
- Patients unable to participate in the consent process
- Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc
- Other conditions that the researcher considers inappropriate to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650118
Yuanyuan Zhu,Doctor, 86+18059766094, 18059766094@163.com
Weiling Chen,Doctor, 86+13646039812, 913208146@qq.com
About this study
Accurate evaluation of tumor boundaries in breast-conserving surgery is closely associated with reducing the second operation of patients. Meanwhile, accurately assessing sentinel lymph node (SLN) metastasis is crucial for determining the extent of axillary lymph node dissection (ALND) and minimizing complications. Near-infrared-II (NIR-II) fluorescence imaging using molecular agents has shown promise for in situ imaging during resection. However, very effective probes can be applied to clinical trials up to now, which limits the clinical application of fluorescence imaging. Here we developed a new technology that can quickly differentiation between cancer and para-cancer tissue as well as metastatic and normal sentinel lymph nodes(SLN). In brief, the fresh tissues were incubated with the probe immediately after intraoperative resection and imaged to identify the tumor area and distinguish the metastatic status of SLN. The accuracy of fluorescence imaging was confirmed by pathological diagnosis.
Read the detailed description
After enrollment, the patients received surgical treatment according to clinical diagnosis and treatment.During the operation, the excised breast tissue and SLN was incubated, and the specific procedure was as follows.
- Preparation of the incubation solution: The probe was dissolved in phosphate buffer saline(PBS) buffer as the incubation solution at room temperature in the dark,with varying concentrations (12.5, 25, 50,100 ug/mL).
- In vitro incubation of fresh breast cancer or SLN tissues: The fresh excision breast cancer and SLN tissues were completely soaked in the incubation solution for about 1,3, 5, 7 or 10 minutes, followed by 5 minutes rinse with PBST buffer (PBS with Tween 20) and drying with the use of absorbent paper.
- Analysis of the images in the "Digital Precision Medicine(DPM)" NIR-II system. The DPM parameter was set up before scaling. Then fluorescence imaging was performed with the DPM NIR-II system. And the result was analyzed to identify the tumor area and distinguish the metastatic status of SLN.
- Confirmed the diagnosis by pathological examination.
- Conditions
- Breast Cancer, Sentinel Lymph Node, Metastases, Margin Assessment
- Being tested
- NIR-II Probe(i.e ICG-POL6326) incubation solution
- Keywords
- NIR-II, Breast Cancer, Sentinel Lymph Node, Surgical Navigation, Metastases
- Medical subject headings
- Breast Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIR-II Probe(i.e ICG-POL6326) incubation solutionDiagnostic test
After the tissues were incubated with the optimal concentration of the NIR-II probe for the appropriate time, the tissues were washed with the eluate, and then the fluorescence intensity of different tissues was detected to evaluate whether the tissues had cancer tissue invasion.
| Study group | Role | What they receive |
|---|---|---|
| NIR-II probe incubation | The fresh excision breast tissues or SLN will be completely soaked in the NIR-II probe (i.e:ICG-POL6326) incubation solution (12.5,25,50,100 ug/mL) for1, 3, 5,7 or 10 min, followed by 5 min of rinsing with PBST buffer and drying with absorbent paper.The NIR-II fluorescence imaging will be then performed under the DPM NIR-II system. And the correlation between pathological characterization and fluorescent information will be further analyzed. Receives: Diagnostic Test: NIR-II Probe(i.e ICG-POL6326) incubation solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of the CXCR4 in the tumor
Ability of the imaging system to detect the expression of the CXCR4 in the mass (i.e tumor).
Measured: 2 year
Uptake of the dye by the tissue(i.e tumor,metastatic SLN)
Ability of the imaging system to discern the uptake of the dye by the tumor or metastatic SLN . Detected with imaging probe.
Measured: 2 year
False positive rates of the NIR-II probe (ICG-POL6326)
Microscopic examination and immunohistochemistry of tumor performed by a pathologist. This will allow investigators to compare pathology results with fluorescence images taken by imaging probe to calculate false positive (i.e., identification of non CXCR4-positive tumors) rates of ICG-POL6326.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start1 Sep 2024
- Primary completion25 Aug 2025 (estimated)
- Study completion25 Dec 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunnan Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xiang'an Hospital of Xiamen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713161
- Sponsor's protocol ID
- KYLX2024-240
- Acronym
- NIR-II
- Status last verified
- Nov 2024
- First submitted
- 27 Nov 2024
- Last updated
- 3 Dec 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 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor-Targeted-NIR-II Fluorescent Molecular Probes for the Identification of Breast Cancer Tissue and SLN Metastatic Status
- ClinicalTrials.gov ID
- NCT06713161
- Acronym / sponsor ID
- NIR-II / KYLX2024-240
- Conditions
- Breast Cancer, Sentinel Lymph Node, Metastases, Margin Assessment
- Keywords
- NIR-II, Breast Cancer, Sentinel Lymph Node, Surgical Navigation, Metastases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yunnan Cancer HospitalUniversity, hospital or other
- Collaborators
- Xiang'an Hospital of Xiamen University
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 25 Aug 2025 (estimated)
- Study completion
- 25 Dec 2025 (estimated)
- First posted
- 3 Dec 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.
Accurate evaluation of tumor boundaries in breast-conserving surgery is closely associated with reducing the second operation of patients. Meanwhile, accurately assessing sentinel lymph node (SLN) metastasis is crucial for determining the extent of axillary lymph node dissection (ALND) and minimizing complications. Near-infrared-II (NIR-II) fluorescence imaging using molecular agents has shown promise for in situ imaging during resection. However, very effective probes can be applied to clinical trials up to now, which limits the clinical application of fluorescence imaging. Here we developed a new technology that can quickly differentiation between cancer and para-cancer tissue as well as metastatic and normal sentinel lymph nodes(SLN). In brief, the fresh tissues were incubated with the probe immediately after intraoperative resection and imaged to identify the tumor area and distinguish the metastatic status of SLN. The accuracy of fluorescence imaging was confirmed by pathological diagnosis.
Detailed description
After enrollment, the patients received surgical treatment according to clinical diagnosis and treatment.During the operation, the excised breast tissue and SLN was incubated, and the specific procedure was as follows.
- Preparation of the incubation solution: The probe was dissolved in phosphate buffer saline(PBS) buffer as the incubation solution at room temperature in the dark,with varying concentrations (12.5, 25, 50,100 ug/mL).
- In vitro incubation of fresh breast cancer or SLN tissues: The fresh excision breast cancer and SLN tissues were completely soaked in the incubation solution for about 1,3, 5, 7 or 10 minutes, followed by 5 minutes rinse with PBST buffer (PBS with Tween 20) and drying with the use of absorbent paper.
- Analysis of the images in the "Digital Precision Medicine(DPM)" NIR-II system. The DPM parameter was set up before scaling. Then fluorescence imaging was performed with the DPM NIR-II system. And the result was analyzed to identify the tumor area and distinguish the metastatic status of SLN.
- Confirmed the diagnosis by pathological examination.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIR-II probe incubation | – | Diagnostic Test: NIR-II Probe(i.e ICG-POL6326) incubation solutionThe fresh excision breast tissues or SLN will be completely soaked in the NIR-II probe (i.e:ICG-POL6326) incubation solution (12.5,25,50,100 ug/mL) for1, 3, 5,7 or 10 min, followed by 5 min of rinsing with PBST buffer and drying with absorbent paper.The NIR-II fluorescence imaging will be then performed under the DPM NIR-II system. And the correlation between pathological characterization and fluorescent information will be further analyzed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators plan to enroll 40 female patients, aged 18 to 75 years, who have been assessed to have resectable breast nodules or masses and are scheduled to undergo surgery. During the surgery, the resected tumors and lymph nodes will be incubated with theNIR-II probe(ICG-POL6326) solution, and NIR-II fluorescence signals from the tissues will be collected.
Key inclusion criteria (5 listed)
- Adult patients between 18-75 years of age
- Female
- Patients presenting with a breast nodule or mass presumed to be resectable on pre-operative assessment
- Good operative candidate
- Subject capable of giving informed consent and participating in the process of consent
Key exclusion criteria (3 listed)
- Patients unable to participate in the consent process
- Patients had contraindications to surgery, such as serious cardiopulmonary disease, coagulation dysfunction, etc
- Other conditions that the researcher considers inappropriate to participate in the study
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 |
|---|---|---|
| NIR-II Probe(i.e ICG-POL6326) incubation solutionAfter the tissues were incubated with the optimal concentration of the NIR-II probe for the appropriate time, the tissues were washed with the eluate, and then the fluorescence intensity of different tissues was detected to evaluate whether the tissues had cancer tissue invasion. | Diagnostic test | NIR-II probe incubation |
Primary outcome
Expression of the CXCR4 in the tumor
Time frame: 2 year
Ability of the imaging system to detect the expression of the CXCR4 in the mass (i.e tumor).
Uptake of the dye by the tissue(i.e tumor,metastatic SLN)
Time frame: 2 year
Ability of the imaging system to discern the uptake of the dye by the tumor or metastatic SLN . Detected with imaging probe.
False positive rates of the NIR-II probe (ICG-POL6326)
Time frame: 2 year
Microscopic examination and immunohistochemistry of tumor performed by a pathologist. This will allow investigators to compare pathology results with fluorescence images taken by imaging probe to calculate false positive (i.e., identification of non CXCR4-positive tumors) rates of ICG-POL6326.
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 3 Dec 2024.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
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 Yunnan Cancer 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 5 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: looking for participants now, as of the sponsor's last update on 3 Dec 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 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?
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?
Contact Yuanyuan Zhu,Doctor (86+18059766094, 18059766094@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of the CXCR4 in the tumor (time frame: 2 year). The study lists 3 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 3 Dec 2024.