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

November 27, 2024 updated by: Yunnan Cancer Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

  1. 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).
  2. 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.
  3. 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.
  4. Confirmed the diagnosis by pathological examination.

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Weiling Chen, Doctor
  • Phone Number: 86+13646039812
  • Email: 913208146@qq.com

Study Locations

  • China
    • Yunnan
      • Kunming, Yunnan, China, 650118
        • Recruiting
        • Yunnan Cancer Hospital
        • Contact:
          • Guojun Zhang, Doctor
        • Contact:
        • Contact:
        • Contact:
          • Yuanyuan Zhu,Doctor
        • Contact:
          • Weiling Chen,Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
2 year
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.
2 year
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.
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yunnan Cancer Hospital

Collaborators

Xiang'an Hospital of Xiamen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

August 25, 2025

Study Completion (Estimated)

December 25, 2025

Study Registration Dates

First Submitted

November 27, 2024

First Submitted That Met QC Criteria

November 27, 2024

First Posted (Actual)

December 3, 2024

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLX2024-240

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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