Who may be eligible for this breast cancer clinical trial?

Women aged 18 to 80 with suspected or confirmed triple-negative breast cancer, including recurrent or metastatic cases, may be eligible. Participants must have had surgical sterilization or be menopausal for over a year. Please review eligibility criteria for more details.

Is there any cost to participate in this breast cancer clinical trial?

Study-related care, including the imaging scans and study procedures, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 80Years

FEMALE

ID06104085

99mTc-MY6349 SPECTCT Imaging in Trop2-positive Triple-negative Breast Cancer

Q: What is 99mTc-MY6349 studying for triple-negative breast cancer?

99mTc-MY6349 is being studied to detect the protein Trop2 in tumors of patients with triple-negative breast cancer. This helps researchers understand tumor characteristics and guide treatment options, especially for those considering targeted therapy with gosatuzumab. The study is sponsored by Peking Union Medical College Hospital.

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

Participants Needed

Research Sites

13 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a new imaging agent called 99mTc-MY6349 to detect the presence of Trop2, a protein highly expressed in many cancers including triple-negative breast cancer. This study aims to monitor Trop2 expression in tumors using SPECTCT scans, helping to understand tumor characteristics and guide treatment decisions for patients considering the anti-Trop2 antibody gosatuzumab. Trop2 expression is linked to tumor growth, spread, and patient outcomes. Participants in this study will receive an injection of 99mTc-MY6349 followed by a SPECTCT scan to observe how well the tracer binds to Trop2 in the tumors. This imaging will be compared to 18F-FDG PETCT scans to analyze tumor locations and spread. The study focuses on triple-negative breast cancer patients and looks at the variation of Trop2 expression within primary and metastatic tumors to help inform potential treatment with gosatuzumab. During the study, participants will undergo imaging scans and evaluations of Trop2 levels in their tumors. Researchers will perform semi-quantitative analysis of the imaging results over about one year. The study monitors the ability of the new imaging method to predict response to targeted treatment and assesses tumor heterogeneity. Participants are expected to be followed until study completion with safety considerations for radiation exposure.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years

FEMALE

Eligibility Criteria

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 recurrent or metastatic triple-negative breast cancer.
Female subjects must have medical records proving surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation) or be menopausal for more than one year; if fertile, must use contraception during the study period.

You will not qualify if you...

Severe gastrointestinal, cardiovascular, liver, kidney, blood, endocrine, respiratory, immune deficiency, or other serious diseases.
Claustrophobia.
Received ionizing radiation exceeding 50mSv within the past year from other treatments or research.
Pregnant or lactating women.
Received experimental drug or device treatment with unclear safety or efficacy within 1 month.
Any condition deemed potentially harmful by the study conductor related to the experiment.

Research Team

Li Huo

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