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Application of CD47-specific PET imaging for non-invasive diagnosis in malignant tumor detection: A cross-sectional, diagnostic clinical study

Application of CD47-specific PET imaging for non-invasive diagnosis in malignant tumor detection: A cross-sectional, diagnostic clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092322
Enrollment
Unknown
Registered
2024-11-14
Start date
2024-11-20
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomach cancer

Interventions

Index test:18F-ABDC2/C2 PET/CT imaging

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The subjects voluntarily participate in this trial and sign the informed consent form; 2. Age >= 18 years and <= 80 years (as of the date of signing the informed consent form), gender is not restricted; 3. Patients suspected of having malignant tumors but without pathological results; 4. The subjects received pathological results within two weeks after undergoing 18F-ABDC2/C2 PET/CT imaging; 5. Physical fitness rating: 0-1 points; 6. Expected survival time exceeds 12 months; 7. Female subjects of childbearing potential, male subjects, and male subjects' partners agree to use reliable contraceptive measures (such as abstinence, sterilization surgery, contraceptive pills, injectable contraceptives like medroxyprogesterone, or subdermal contraceptive implants) for 6 months after the last infusion of the study drug; 8. Willing and able to comply with scheduled visits, diagnostic plans, clinical laboratory tests, and other trial procedures.

Exclusion criteria

Exclusion criteria: 1. Patients who have received anti-tumor treatment prior to the PET/CT scan; 2. Individuals with severe other neurological diseases, or gastrointestinal, cardiovascular, liver, kidney, hematological, respiratory, immunodeficiency, and other serious illnesses; 3. There are some alternative subjects for whom PET/CT scans are contraindicated. This includes, but is not limited to: patients with uncontrolled blood sugar; pregnant women, breastfeeding women, or women who are in the breastfeeding period; individuals who cannot tolerate repeated intravenous injections; and those who may be allergic to the medication (Including a history of severe allergies or allergic reactions, especially for those allergic to the tested medication); claustrophobia; 4. In the past year, in addition to the expected radiation exposure from participating in this clinical study, there have been other research protocols or clinical care that resulted in an effective dose of radiation exposure exceeding 50 mSv; 5. Alternative subjects have undergone major surgery within the past three months; have received experimental drugs or device treatments within the past month (the effects or safety of which are unclear); 6. Alternative subjects have any clinical conditions that the study sponsor believes may cause or pose potential harm from this formulation.

Design outcomes

Primary

MeasureTime frame
Tumor SUV value;Sensitivity, specificity, and accuracy;

Countries

China

Contacts

Public ContactJun Li

Peking University Shenzhen Hospital

lijunactive@126.com+86 755 83923333

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026