A Study to Evaluate the Diagnostic Efficacy of 68Ga- MY6349 PET/CT in Patients With Tumours

Launched by XIJING HOSPITAL · Jan 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging technique called 68Ga-MY6349 to see how well it can help doctors diagnose, stage, and monitor recurrence of tumors that come from epithelial cells (the cells that line many organs). The trial will involve 40 patients who have these types of tumors and will compare the effectiveness of 68Ga-MY6349 with other imaging methods, using the results from surgeries as a standard for accuracy.

To participate, you need to be at least 18 years old and have a confirmed tumor that may need surgery. You should also expect to live for at least three more months, according to your doctor. If you have a severe allergy to the substances used in the imaging, cannot receive IV treatments, or have other serious health issues, you may not be eligible. Participants will undergo imaging tests and may help contribute to better ways of diagnosing and monitoring these tumors in the future. If you decide to join, you’ll need to sign a consent form and follow the study guidelines.

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Eligibility criteria

• Inclusion Criteria:
• • - Age ≥ 18 years; Patients with pathologically confirmed tumour and proposed surgical resection/exploration (including primary or recurrent metastatic tumour); Expected survival \> 3 months, as judged by the doctor; Voluntarily sign the informed consent form; willing and able to follow the study protocol
• Exclusion Criteria:
• • - Persons with a known history of hypersensitivity to 68Ga-MY6349 and 68Ga-PSMA or 18F-FDG and their excipients; Those who cannot tolerate intravenous drug delivery methods (e.g., history of needle and blood sickness); Patients who have received anti-tumour therapy before the examination or neoadjuvant chemotherapy/targeted therapy for tumour reduction after the examination and up to the preoperative period; Pregnant and lactating women; Practitioners who need to be exposed to radioactive conditions for a long time; Serious diseases of heart, kidney, lung, vascular, neurological and psychiatric systems, immunodeficiency diseases and hepatitis/cirrhosis; Have participated in other interventional clinical trials within 1 month prior to screening; Patients undergoing chemotherapy, immunotherapy or molecular targeted therapy; Presence of other conditions that, in the opinion of the investigator, make participation in this study unsuitable.