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CD147 Targeting Nanobody Probe for PET Imaging in Solid Tumors

NCT ID: NCT06646952

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-31

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Solid Tumor

Keywords

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CD147 solid tumor

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

18F-FDG

Intervention Type DRUG

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

Interventions

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18F-FDG

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hua Zhu

OTHER

Sponsor Role lead

Responsible Party

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Hua Zhu

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hua Zhu

Role: CONTACT

Phone: 010-88196495

Email: [email protected]

Zhi Yang

Role: CONTACT

Phone: 010-88196196

Email: [email protected]

Facility Contacts

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Hua Zhu

Role: primary

Other Identifiers

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2024KT10

Identifier Type: -

Identifier Source: org_study_id