Malignant Solid Tumors of Epithelial Origin
Conditions
Interventions
Experimental group:Intravenous injection of 68Ga-PMD014,followed by PET/CT imaging.
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adults aged >=18 years (as of the date of signing the informed consent form), both male and female are eligible. 2. Subjects with pathologically confirmed malignant solid tumors of epithelial origin (including but not limited to gastric cancer, esophageal cancer, ovarian cancer, endometrial cancer, non-small cell lung cancer) with suspected lymph node metastasis who are planned to undergo surgery and lymph node dissection. 3. Estimated survival time >= 12 weeks; 4. Subjects of child-bearing potential agree to use effective contraceptive measures during the trial. 5. Subjects understand the trial, participate voluntarily, sign the informed consent form, and are willing to complete the trial in accordance with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1. History of allergy or intolerance to any component of the investigational drug. 2. Patients with poor general condition who cannot tolerate surgery due to dysfunction of vital organs such as the heart, lungs, liver, kidneys and brain. 3. Subjects unable to tolerate intravenous administration (e.g., history of needle-phobia or blood-phobia); 4. Subjects with symptomatic brain metastases requiring treatment; 5. With severe or uncontrolled psychiatric disorders; 6. With severe cardiovascular and cerebrovascular diseases, including but not limited to: acute coronary syndrome, congestive heart failure, aortic dissection, stroke, or other grade 3 and above cardiovascular and cerebrovascular events occurring within 6 months prior to drug administration; 7. Subjects with known severe urinary incontinence, hydronephrosis, or severe voiding dysfunction (subjects with bladder outlet obstruction or urinary incontinence controlled by optimal standard care are eligible). 8. Subjects who are deemed unsuitable for or unable to complete imaging examinations such as PET/CT for special reasons by the investigator, including those with claustrophobia, radiophobia, etc. 9. Pregnant women (positive pregnancy test during screening) or breastfeeding women; 10. Subjects who have participated in other interventional clinical trials within 1 month prior to screening; 11. Other conditions deemed inappropriate for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity?Specificity?Accuracy?Positive Predictive Value?Negative Predictive Value; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Biodistribution;Efficacy Evaluation;Efficacy Evaluation;Efficacy Evaluation;Exploratory Evaluation; | — |
Countries
China
Contacts
Public ContactRui Gao
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed