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Clinical Study of 68Ga-NOTA-A9 PET Imaging for Evaluating CD276 Expression in Malignant Tumors

Clinical Study of 68Ga-NOTA-A9 PET Imaging for Evaluating CD276 Expression in Malignant Tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600124967
Enrollment
Unknown
Registered
2026-05-19
Start date
2026-05-20
Completion date
Unknown
Last updated
2026-05-25

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

Conditions

Lung cancer and esophageal cancer

Interventions

Index test:68Ga-NOTA-A9 PET

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Adult patients (18 years and older), gender not limited; 2. Four untreated, newly diagnosed patients with lung cancer or esophageal cancer will be included in the study and analysis; 3. Patients who can provide informed consent (signed by the individual if capable of giving informed consent; signed by the participant, family member, or legal representative if unable to give informed consent) and who consent according to the guidelines of the Clinical Research Ethics Committee; 4. Complete blood count: White blood cell count (WBC) 4~10×10^9/L; Platelet count (PLT) 100~300 ×10^9/L; Hemoglobin (HB) 120~160 g/L; 5. Renal function: Serum creatinine less than or equal to the upper limit of the normal range; 6. Liver function: Bilirubin, AST (SGOT)/ALT (SGPT) less than or equal to the upper limit of the normal range; 7. Electrocardiogram: No significant abnormalities; 8. Patients of childbearing age can cooperate with contraception.

Exclusion criteria

Exclusion criteria: 1. The candidate study participant has contraindications to PET/CT scanning. This includes, but is not limited to, uncontrolled hyperglycemia; pregnancy, lactation, or breastfeeding women; inability to receive repeated intravenous injections; potential allergies to the drug or its components (including a history of severe allergies or allergic reactions, especially to the drug being tested); claustrophobia; 2. In the past year, in addition to the radiation exposure expected in this clinical study, the candidate has participated in other research protocols or clinical care that resulted in radiation exposure exceeding the effective dose of 50 mSv; 3. The candidate study participant has the following uncontrollable clinical conditions: including but not limited to systemic diseases such as coronary artery disease, heart failure, unstable angina or arrhythmia, uremia, liver failure, sudden stroke, acute myocardial infarction, and unstable diabetes. They may have a history of head injury, intracranial surgery; hypoxia, sepsis, or severe infectious diseases; mental disorders, epilepsy, and major depressive disorder or a history of such conditions; or a history of a positive HIV test; 4. The candidate study participant has significant abnormalities in laboratory tests, which are considered clinically significant or unstable; 5. Drug abuse or alcoholism for at least 3 months; 6. The candidate study participant has any clinical condition that the study principal investigator believes may cause or has potential harm from this preparation; 7. Possible allergy to any component of the 68Ga-NOTA-A9 injection.

Design outcomes

Primary

MeasureTime frame
Standardized Uptake Value;Tumor-to-Background Ratio;

Countries

China

Contacts

Public ContactYihui Guan

Huashan Hospital, Fudan University

guanyihui@hotmail.com+86 137 6430 8300

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026