Actively Recruiting
A Clinical Study to Evaluate 68Ga-MY6349 PET/CT for Diagnosing, Staging, and Monitoring Tumours of Epithelial Origin
Led by Xijing Hospital · Updated on 2025-01-17
40
Participants Needed
1
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the diagnostic ability of a new imaging agent called 68Ga-MY6349 in patients with tumors of epithelial origin. This study aims to compare the effectiveness of 68Ga-MY6349 PET/CT imaging with 68Ga-PSMA/18F-FDG PET/CT scans for diagnosing, staging, and monitoring tumor recurrence, using pathological findings as the reference standard. The study plans to enroll 40 patients with confirmed epithelial tumors who are scheduled for surgical resection or exploration. Participants will receive an intravenous injection of the 68Ga-MY6349 imaging agent, which is prepared under strict quality standards. The dose ranges from 0.05 to 0.1 mCi/kg, followed by a saline flush. The imaging agent is clear, colorless, and has a radioactive half-life of 68 minutes. Each participant will undergo PET/CT scans to assess tumor activity using the 68Ga-MY6349 tracer. During the study, researchers will measure imaging outcomes such as the maximum standardized uptake value (SUVmax) and the tumor to background ratio (TBR) one day after tracer injection. Participants will be monitored for adverse reactions and overall safety. The study includes patients aged 18 to 80 who agree to follow the protocol and provide informed consent. The total duration and further follow-up details were not specified.
CONDITIONS
Official Title
A Study to Evaluate the Diagnostic Efficacy of 68Ga- MY6349 PET/CT in Patients With Tumours
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Pathologically confirmed tumor with planned surgical resection or exploration (including primary or recurrent metastatic tumor)
- Expected survival longer than 3 months as judged by the doctor
- Voluntarily sign informed consent
- Willing and able to follow the study protocol
You will not qualify if you...
- Known allergy to 68Ga-MY6349, 68Ga-PSMA, 18F-FDG, or their excipients
- Unable to tolerate intravenous drug delivery methods (e.g., history of needle or blood sickness)
- Received anti-tumor therapy before the examination or neoadjuvant chemotherapy/targeted therapy after examination before surgery
- Pregnant or breastfeeding women
- Professionals needing long-term exposure to radioactive conditions
- Serious heart, kidney, lung, vascular, neurological, psychiatric diseases, immunodeficiency, hepatitis, or cirrhosis
- Participated in other interventional clinical trials within 1 month prior to screening
- Currently undergoing chemotherapy, immunotherapy, or molecular targeted therapy
- Other conditions making study participation unsuitable according to the investigator
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Trial Site Locations
Total: 1 location
1
Department of Nuclear Medicine,Xijing Hospital, Fourth Military Medical University, Xi'an, China
Xi'an, Shaanxi, China
Actively Recruiting
Research Team
Y
Ying Guo Ying Guo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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