Ovarian cancer
Conditions
Interventions
Index test:PET Imaging Targeting VEGFR-3
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Tumor subjects: the subject or his/her legal representative is able to sign the informed consent form signature and date; 2.Tumor subjects: Commitment to comply with the research procedures and cooperation in the implementation of the whole research process; 3.Tumor subjects: Adult patients or healthy volunteers (age 18 or older), male or female; 4.Tumor subjects: Patients with clinically suspected or confirmed malignant tumors such as ovarian, cervical, and breast cancers (supporting evidence includes serum-related tumor markers, imaging data such as ultrasound, CT, MRI, etc. and histopathological examination) and in good general condition; 5.Tumor subjects: Compliance with specific laboratory findings; 6.Tumor subjects: Females of childbearing potential who have been using contraception for at least one month prior to screening and who are committed to using contraception for the entire study period and until a specified time after the end of the study; 7.Tumor subjects: Other set entry criteria; 8.Healthy subjects: fully understand and voluntarily sign the informed consent form; 9.Healthy subjects: Men and women of either sex, aged 18-70 years; 10.Healthy subjects: Male weight = 50.0kg, female weight = 45.0kg; body mass index (BMI) within the range of 19.0~26.0kg/m2 (including critical values); 11.Healthy subjects: No history of chronic or serious diseases of the cardiovascular, hepatic, renal, respiratory, hematologic and lymphatic, endocrine, immunologic, psychiatric, neuromuscular, or gastrointestinal systems within three years, and in good general health; 12.Healthy subjects: Vital signs check, no abnormalities on physical examination; 13.Healthy subjects: Not planning to have children and voluntarily using effective contraception during the trial period and for 6 months after the completion of the trial, and not planning to donate sperm or eggs; 14.Healthy subjects: Able to communicate well with the researcher and understand and comply with the requirements of this study;
Exclusion criteria
Exclusion criteria: 1.Tumor subjects: Those unable to complete a PET/MR or PET/CT examination (including inability to lie flat, claustrophobia, radiophobia, etc.); 2.Tumor subjects: Patients with known hypersensitivity to TMVP1446 peptide fragment developer or synthetic excipients; fasting blood glucose level greater than 11.0 mmol/L prior to 18F-FDG injection; 3.Tumor subjects: Patients who are pregnant or breastfeeding; 4.Tumor subjects: Persons with other factors that make participation in this trial inadvisable; 5.Healthy subjects: Any serious or unstable medical condition; those who had an acute illness prior to the study; previous or current malignancies; 6.Healthy subjects: Pregnant and lactating women; 7.Healthy subjects: Those who have undergone surgery within 6 months prior to the trial that, in the judgment of the investigator, would interfere with absorption, distribution, metabolism, or excretion; 8.Healthy subjects: Those who have used any medication (including prescription, over-the-counter, herbal) in the 2 weeks prior to the trial; 9.Healthy subjects: Participated in other research involving radioactive materials (within the last 12 months); 10.Healthy subjects: Any other factors affecting study results;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standardized uptake values assessment of region of interest;Accuracy;Sensitivity;Specificity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological section of tumor tissue;Radioactivity in the blood and urine samples;electrocardiography,ECG;Blood routine, urine routine, liver and kidney function and other biochemical indicators; | — |
Countries
China
Contacts
Public ContactXiaoli Lan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed