NIR Fluorescent Molecular Probe for the Identification of Breast Tissue

NCT05708144 | Completed

• 1 other identifier: XianganHXiamenU
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast tissue; NIR-II; Trop-2; diagnosis

Outcome Measures

Primary Outcomes (3)

• Expression of the trop-2 in the tumor

  Ability of the imaging system to detect the expression of the trop-2 in the mass (i.e tumor).

  2 years

• Uptake of the dye by the tumor

  Ability of the imaging system to discern the uptake of the dye by the tumor. Detected with imaging probe.

  2 years

• False positive rates of ICG-SG

  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 Trop2-positive tumors) rates of ICG-SG.

  2 years

Secondary Outcomes (1)

• Incidence rates of all adverse events (AEs)

  2 years

Study Arms (1)

Indocyanine green-Sacituzumab govitecan-hziy (ICG-SG)

EXPERIMENTAL

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

Interventions

ICG-SG incubation solution DIAGNOSTIC_TEST

The fresh excision breast cancer tissues were completely soaked in the incubation solution and performed fluorescence imaging.

Indocyanine green-Sacituzumab govitecan-hziy (ICG-SG)

Eligibility Criteria

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

You may qualify if:

• 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.

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

• Xiang'an Hospital of Xiamen University: lead

Study Sites (1)

Xiamen Key Laboratory of Endocrine-Related Cancer Precision Medicine

Xiamen, Fujian, 361000, China

Location

Related Publications (1)

• Li C, Mi J, Wang Y, Zhang Z, Guo X, Zhou J, Hu Z, Tian J. New and effective EGFR-targeted fluorescence imaging technology for intraoperative rapid determination of lung cancer in freshly isolated tissue. Eur J Nucl Med Mol Imaging. 2023 Jan;50(2):494-507. doi: 10.1007/s00259-022-05975-7. Epub 2022 Oct 8.

  PMID: 36207638 BACKGROUND

Related Links

• A new fluorescence imaging technology for intraoperative rapid determination of lung cancer in freshly isolated tissue

MeSH Terms

Conditions

Breast Neoplasms; Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Guojun Zhang, MD

  Xiang'an Hospital of Xiamen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending doctor

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: February 1, 2023
• Study Start: February 17, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)