Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
FEMALE
NCT06104085

99mTc-MY6349 SPECT/CT Imaging in Trop2-positive Triple-negative Breast Cancer

Led by Peking Union Medical College Hospital · Updated on 2023-10-27

30

Participants Needed

1

Research Sites

172 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Human trophoblast cell-surface glycoprotein antigen 2 (Trop2) is a membrane surface receptor that plays an important role in the occurrence and development of tumors. Studies have shown that Trop2 is highly expressed in a variety of cancers (such as breast cancer, lung cancer, gastric cancer, colorectal cancer, pancreatic cancer, prostate cancer, cervical cancer, head and neck cancer, and ovarian cancer, etc.) and is related to the proliferation, invasion, and metastasis of tumor cells. and other processes related. According to statistics, more than 80% of breast cancer patients highly express Trop2, and high expression of Trop2 is positively correlated with shortened survival and poor prognosis of cancer patients. In this study, a single-domain antibody targeting Trop2 was selected to prepare a new nuclear medicine molecular probe 99mTc-MY6349, so as to monitor the expression level of Trop2 in patients' systemic tumors through SPECT/CT imaging. Breast cancer patients who intend to use gosatuzumab for subsequent treatment can first undergo 99mTc-MY6349 SPECT/CT imaging to detect Trop2 expression levels in systemic tumors. Subsequently, 18F-FDG PET/CT imaging was performed to compare and detect the distribution of primary tumors and systemic metastases in patients with breast cancer. This study analyzes the heterogeneity of Trop2 expression levels within the primary tumor and the heterogeneity of expression levels in systemic metastases, thereby providing a basis for testing whether the patient is suitable for subsequent treatment and conducive to the formulation of subsequent treatment plans.

CONDITIONS

Official Title

99mTc-MY6349 SPECT/CT Imaging in Trop2-positive Triple-negative Breast Cancer

Who Can Participate

Age: 18Years - 80Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female, aged between 18 and 80 years old.
  • Suspected or confirmed diagnosis of triple-negative breast cancer.
  • Suspected or confirmed triple-negative recurrent or metastatic breast cancer.
  • Female participants must have medical proof of surgical sterilization or be menopausal for more than one year; if still able to conceive, contraceptive measures must be used during the study.
Not Eligible

You will not qualify if you...

  • Severe diseases affecting gastrointestinal, cardiovascular, liver, kidney, blood, endocrine, respiratory, or immune systems.
  • Claustrophobia.
  • Radiation exposure exceeding 50mSv in the past year from other clinical or research treatments.
  • Pregnant or lactating women.
  • Received experimental drugs or devices with unknown safety or efficacy within 1 month.
  • Any condition that the study conductor believes may cause harm or risk during the study.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

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Research Team

L

Li Huo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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