Tumor-Targeted-NIR-II Fluorescent Molecular Probes for the Identification of Breast Cancer Tissue and SLN Metastatic Status

NCT06713161 | Recruiting DMC

• 1 other identifier: KYLX2024-240
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Cancer; Sentinel Lymph Node; Metastases; Margin Assessment

Keywords

NIR-II; Breast Cancer; Sentinel Lymph Node; Surgical Navigation; Metastases

Outcome Measures

Primary Outcomes (3)

• 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).

  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.

  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.

  2 year

Study Arms (1)

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.

Diagnostic Test: NIR-II Probe(i.e ICG-POL6326) incubation solution

Interventions

NIR-II Probe(i.e ICG-POL6326) incubation solution DIAGNOSTIC_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.

NIR-II probe incubation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yunnan Cancer Hospital: lead
• Xiang'an Hospital of Xiamen University: collaborator

Study Sites (1)

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

RECRUITING

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yuanyuan Zhu,Doctor

CONTACT

86+18059766094; 18059766094@163.com

Weiling Chen, Doctor

CONTACT

86+13646039812; 913208146@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 3, 2024
• Study Start: September 1, 2024
• Primary Completion: August 25, 2025
• Study Completion: December 25, 2025
• Last Updated: December 3, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)