Using a special probe for PET imaging of solid tumors

CD147 Targeting Nanobody Probe for PET Imaging in Solid Tumors

This study is testing a new imaging method to see if it can help find specific solid tumors that have a marker called CD147, so that doctors can figure out who might benefit from targeted treatments.

Quick facts

• Study type: Observational
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Peking University Cancer Hospital & Institute (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06646952 on ClinicalTrials.gov

What this trial studies

This study aims to develop a noninvasive method utilizing 68Ga-NOTA-MAL-NB147 PET/CT imaging to detect CD147 expression in solid tumors. By identifying patients with solid tumors who express CD147, the study seeks to determine which individuals may benefit from targeted CD147 therapies. Participants will undergo PET scans and may provide biopsy samples for further analysis. The study focuses on various types of solid tumors, including melanoma, liver, colorectal, pancreatic, breast, gastric, and lung cancers.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with confirmed diagnoses of specific solid tumors and accessible lesions for biopsy.

Not a fit: Patients with solid tumors that do not express CD147 or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance the ability to identify patients who are likely to respond to CD147-targeting treatments.

How similar studies have performed: While this approach is innovative, similar studies targeting tumor markers for imaging have shown promise, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Histopathologically or cytologically confirmed malignant melanoma, hepatocellular carcinoma, colorectal cancer, pancreatic cancer, breast cancer, gastric cancer, and lung cancer.
2. Aged ≥18 and ≤75 years, with no gender restrictions.
3. ECOG score of 0 or 1.
4. Expected survival time ≥6 months.
5. At least one easily accessible lesion that can be biopsied within one month before or after the PET scan. The patient consents to using archived or fresh biopsy tissue samples for relevant analysis.
6. Blood routine and liver/kidney function must meet the following criteria: Blood routine: WBC ≥ 4.0×10⁹/L or neutrophils ≥ 1.5×10⁹/L, PLT ≥ 100×10⁹/L, Hb ≥ 90 g/L; PT or APTT ≤ 1.5 ULN; Liver/kidney function: T-Bil ≤ 1.5×ULN (upper limit of normal), ALT/AST ≤ 2.5×ULN or 5×ULN (for subjects with liver metastases), ALP ≤ 2.5×ULN (if bone or liver metastases exist, ALP ≤ 4.5×ULN); BUN ≤ 1.5×ULN; SCr ≤ 1.5×ULN; At least one measurable target lesion according to RECIST 1.1 criteria.
7. Women must use contraceptive measures during the study or for six months after the study ends (effective contraceptive methods include sterilization, hormonal intrauterine devices, condoms, contraceptive pills/devices, abstinence, or partner tubal ligation, etc.). Men must agree to use contraceptive measures during the study or for six months after the study ends.
8. Able to understand and voluntarily sign the informed consent form, with good compliance.

Exclusion Criteria:

1. Pregnant or breastfeeding women, or women planning to become pregnant during the study or within three months after administration, as well as individuals donating sperm or oocytes.
2. Individuals known or suspected to be allergic to the investigational drug or any of its components.
3. Individuals with significantly abnormal liver or kidney function: serum total bilirubin (TBIL) \> 1.5 × 20 µmol/L, or aspartate aminotransferase (AST) \> 2.5 × 45 µmol/L, or alanine aminotransferase (ALT) \> 2.5 × 40 µmol/L, or serum creatinine \> 1.5 × 130 µmol/L.
4. Unable to cooperate in completing the PET scan, or suffering from claustrophobia or other conditions that prevent cooperation during the PET scan.
5. Other situations deemed inappropriate for participation in the trial by the investigator. Female patients who are pregnant or breastfeeding.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Hua Zhu

Conditions Solid Tumor; CD147; solid tumor