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NIR Fluorescent Molecular Probe for the Identification of Breast Tissue

Sponsor
Weiling Chen，MD (Other)
Overall Status
Recruiting
CT.gov ID
NCT05708144
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
11
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Accurate evaluation of tumor boundaries in breast-conserving surgery is critical to reducing the second operation of patients. Near-infrared (NIR) 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 identify the tumor area of the resected breast tissue during the operation and distinguish the tumor boundary. In brief, the breast tissues were incubated with the probe immediately after intraoperative resection and imaged to identify the tumor area and distinguish the tumor boundary. The accuracy of fluorescence imaging was confirmed by pathological diagnosis.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: ICG-SG incubation solution
 N/A

Detailed Description

After enrollment, the patients received surgical treatment according to clinical diagnosis and treatment. During the operation, the excised breast tissue was incubated, and the specific procedure was as follows.

  1. Preparation of the incubation solution: The probe was dissolved in PBS buffer as the incubation solution at room temperature in the dark.

  2. In vitro incubation of fresh breast cancer tissues: The fresh excision breast cancer tissues were completely soaked in the incubation solution for about 10 minutes, followed by 5 minutes rinse with PBS buffer and drying with the use of absorbent paper.

  3. Analysis of the images in the 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 tumor boundary.

  4. Confirmed the diagnosis by pathological examination.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Study of a Novel Near-infrared(NIR) Fluorescent Molecular Probe Targeting Trop-2 for the Identification of Benign and Malignant Breast Tissue
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Oct 30, 2023
Anticipated Study Completion Date :
Jan 29, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: ICG-SG

The fresh excision breast cancer tissues were completely soaked in the ICG-SG incubation solution for about 10 minutes, followed by 5 minutes of rinsing with PBS buffer and drying with the use of absorbent paper. Then fluorescence imaging was performed with the DPM NIR-II system. And the result was analyzed to identify the tumor area and distinguish the tumor boundary.

Diagnostic Test: ICG-SG incubation solution
The fresh excision breast cancer tissues were completely soaked in the incubation solution and performed fluorescence imaging.

Outcome Measures

Primary Outcome Measures

  1. Ability of the imaging system to detect the expression of the trop-2 in the mass (i.e tumor) and discern the uptake of the dye by the tumor. [2 years]

    Detected with imaging probe.

  2. Microscopic examination and immunohistochemistry of tumor. [2 years]

    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 Trop2-positive tumors) rates of ICG-SG.

Secondary Outcome Measures

  1. Incidence rates of all AEs [2 years]

    Tissue incubation adverse events and adverse device events (ADEs)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Adult patients over 18 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xiamen Key Laboratory of Endocrine-Related Cancer Precision Medicine Xiamen Fujian China 361000

Sponsors and Collaborators

  • Weiling Chen，MD

Investigators

  • Study Director: Guojun Zhang, MD, Xiang'an Hospital of Xiamen University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Weiling Chen，MD, attending doctor, Xiang'an Hospital of Xiamen University
ClinicalTrials.gov Identifier:
NCT05708144
Other Study ID Numbers:
  • XianganHXiamenU
First Posted:
Feb 1, 2023
Last Update Posted:
Feb 1, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Weiling Chen，MD, attending doctor, Xiang'an Hospital of Xiamen University
breast tissue; NIR-II; Trop-2; diagnosis

Study Results

No Results Posted as of Feb 1, 2023