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NCT Number: NCT06720298

CD147 Targeting Peptide Probe for PET Imaging in Solid Tumors

The objective of the study is to construct a noninvasive approach using 68Ga-DOTA-AP9 PET/CT to detect the CD147 expression of tumor lesions in patients with solid tumors and to identify patients benefiting from CD147 targeting treatment.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Malignant melanoma, liver cancer, colon cancer, pancreatic cancer, breast cancer, gastric cancer, lung cancer, etc., confirmed by histopathology or cytology;
  • age ≥18 and ≤75 years old, male or female;
  • ECOG score 0 or 1;
  • expected survival time ≥6 months;
  • There was at least one measurable target lesion according to RECIST1.1 criteria, and biopsy could be performed within one month before and after PET scan, and the patient could provide 2-3 lesion tissue slides;
  • Women of childbearing age (15-49 years) must have had a negative pregnancy test within 7 days before starting testing; Women and men of childbearing potential must agree to use effective contraception to avoid pregnancy during the study and for 3 months after the examination;
  • patients recommended by clinicians to undergo PET/CT examination for tumor staging;
  • The subjects could fully understand and voluntarily participate in this experiment, and signed an informed consent.

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.

Treatment and study plan

18F-FDG

Drug

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

Primary outcomes

  1. Standardized uptake value(SUV)

    Time frame: 2 years

    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-DOTA-AP9) in solid tumor lesions by measuring SUV on PET/CT.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 6, 2024
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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