68Ga-MY6349, Tumour of Epithelial Origin
Conditions
Keywords
68Ga-PSMA, 68GA-MY6349, 18F-FDG, PET/CT
Brief summary
This is a study using an autocontrol approach, enrolling 40 patients with tumours of epithelial origin, who underwent 68Ga- MY6349 and 68Ga-PSMA/18F-FDG PET/CT imaging of patients with tumours of epithelial origin to compare the ability to diagnose, stage and monitor recurrence of tumours of epithelial origin using the pathological findings as the gold standard.
Interventions
DIAGNOSTIC_TEST68Ga-MY6349 PET/CT Scan
The imaging agent 68Ga-MY6349 used in this project is synthesized following the standards for radiopharmaceutical production, with reference to the Chinese Pharmacopoeia (quality standards for 18F-FDG). The pH value is between 5.0 and 8.0; the radiochemical purity is not less than 95%, and the bacterial endotoxin content in each milliliter of solution is less than 15EU; the radioactive concentration is not less than 37 MBq/mL; the solvent residues comply with the regulations. Specification: 185\ 1850 MBq/ml Characteristics: Clear, colorless, no visible particles. Radioactive physical half-life: 68Ga is 68 minutes. Expiry: Calculated from the time of labeling, stable for 3 half-lives. Administration method: Intravenous injection. Dosage: 0.05-0.1mCi/kg, flush with 5 mL of saline after injection.
Sponsors
Xijing Hospital
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
before-after study in the same patient
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Standardized uptake value (SUVmax) | 1 day from injection of the tracer | Maximum Standardized uptake value (SUVmax) of 68Ga-MY6349 and 68Ga-PSMA/18F-FDG in the included subjects' primary and/or metastatic lesions. |
| Tumor to Background Ratio(TBR) | 1 day from injection of the tracer | TBR=SUVmax/SUVmean |
Countries
China
Contacts
Primary ContactYing Guo Ying Guo
Outcome results
None listed