Recruiting NCT06646952
CD147 Targeting Nanobody Probe for PET Imaging in Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18F-FDG.
- Who it may be relevant to
- Registry conditions: Solid Tumor. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The objective of the study is to construct a noninvasive approach using 68Ga-NOTA-MAL-NB147 PET/CT to detect the CD147 expression of tumor lesions in patients with Solid tumors and to identify patients benefiting from CD147 targeting treatment.
Interventions
- Drug 18F-FDG
All study participants will undergo one 18F-FDG PET/ CT scan.
Primary outcome measures
- Standardized uptake value（SUV） [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- Histopathologically or cytologically confirmed malignant melanoma, hepatocellular carcinoma, colorectal cancer, pancreatic cancer, breast cancer, gastric cancer, and lung cancer.
- Aged ≥18 and ≤75 years, with no gender restrictions.
- ECOG score of 0 or 1.
- Expected survival time ≥6 months.
- 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.
- 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.
- 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.
- Able to understand and voluntarily sign the informed consent form, with good compliance.
Exclusion criteria
- 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.
- Individuals known or suspected to be allergic to the investigational drug or any of its components.
- 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.
- Unable to cooperate in completing the PET scan, or suffering from claustrophobia or other conditions that prevent cooperation during the PET scan.
- Other situations deemed inappropriate for participation in the trial by the investigator. Female patients who are pregnant or breastfeeding.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Beijing Cancer Hospital — Beijing
Identifiers
NCT: NCT06646952 · 2024KT10