CD147 Targeting Nanobody Probe for PET Imaging in Solid Tumors

NCT06646952 | Recruiting

• 1 other identifier: 2024KT10
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Solid Tumor

Keywords

CD147; solid tumor

Outcome Measures

Primary Outcomes (1)

• Standardized uptake value（SUV）

  SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions。 The uptake of the tracer （68Ga-NOTA-MAL-NB147） in solid tumor lesions by measuring SUV on PET/CT.

  2 years

Study Arms (1)

68Ga-NOTA-MAL-NB147

All enrolled participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-NOTA-MAL-NB147 PET/CT scan.

Drug: 18F-FDG

Interventions

18F-FDG DRUG

All study participants will undergo one 18F-FDG PET/ CT scan.

68Ga-NOTA-MAL-NB147

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Malignant tumor patients or suspected patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hua Zhu: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

Fluorodeoxyglucose F18

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Central Study Contacts

Hua Zhu

CONTACT

010-88196495; zhuhuabch@pku.edu.cn

Zhi Yang

CONTACT

010-88196196; pekyz@163.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 17, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)