Evaluating a new PET/CT scan for diagnosing epithelial tumors
68Ga-MY6349 A Clinical Study of the Diagnostic Efficacy of PET/CT for Tumours of Epithelial Origin
This study is testing a new type of PET/CT scan to see if it can better diagnose and monitor patients with epithelial tumors compared to an existing scan.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT06770478 on ClinicalTrials.gov |
What this trial studies
This study evaluates the diagnostic efficacy of 68Ga-MY6349 PET/CT imaging in patients with tumors of epithelial origin. It employs an autocontrol approach, enrolling 40 patients who will undergo both 68Ga-MY6349 and 68Ga-PSMA/18F-FDG PET/CT scans. The goal is to compare the effectiveness of these imaging techniques in diagnosing, staging, and monitoring tumor recurrence, using pathological findings as the gold standard for assessment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with pathologically confirmed tumors of epithelial origin who are scheduled for surgical resection.
Not a fit: Patients with a history of hypersensitivity to the imaging agents or those who have received prior anti-tumor therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing and monitoring epithelial tumors, leading to better patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies using PET/CT imaging have shown promise in improving diagnostic accuracy for various tumors.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Xi'an, Shaanxi
- Department of Nuclear Medicine,Xijing Hospital, Fourth Military Medical University, Xi'an, China — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Ying Guo Ying Guo
- Email: guoying01192022@163.com
- Phone: 0086+15991459177
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.