[99mTc]Tc-MY6349 Probe for Trop2-Targeted SPECT Imaging: From Preclinical to Pilot Clinical Study.
Yining Sun, Zhixin Hao, Hannan Gao...
https://pubmed.ncbi.nlm.nih.gov/39947911Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
FEMALE
ID06104085
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
13 weeks
Total Duration
On this page
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 SPECT/CT 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 SPECT/CT scan to observe how well the tracer binds to Trop2 in the tumors. This imaging will be compared to 18F-FDG PET/CT 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 1 year
Participants undergo 99mTc-MY6349 injection followed by SPECT/CT imaging to evaluate the binding of the tracer to Trop2 in the tumor and assess diagnostic efficacy.
1 visit for imaging; assessments may continue through study completion
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
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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