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NCT Number: NCT06713161

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

Location status: Recruiting

Location contact

Guojun Zhang, Doctor

CONTACT

Weiling Chen,Doctor

CONTACT

[email protected]

86+13646039812

Weiling Chen,Doctor

CONTACT

Yuanyuan Zhu,Doctor

CONTACT

[email protected]

86+18059766094

Yuanyuan Zhu,Doctor

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Weiling Chen, Doctor

CONTACT

[email protected]

86+13646039812

Yuanyuan Zhu,Doctor

CONTACT

[email protected]

86+18059766094

Sponsors and collaborators

Lead sponsor

Yunnan Cancer Hospital

Other

Collaborators

  • Xiang'an Hospital of Xiamen University

Registry information

Acronym: NIR-II

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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