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NCT Number: NCT06289517

PET Imaging of 68Ga-Her2-affibody in Tumors with High Her2 Expression

This project uses HER2 protein as the target group of radiodrugs to explore the diagnostic efficacy, safety and metabolic characteristics of 68Ga-Her2-affibody in the expression status of HER2, aiming to provide a new imaging method for the determination of HER2 status in breast cancer At the same time, it also provides new methods and means for early diagnosis, accurate staging, recurrence judgment, treatment decision-making and prognosis judgment of malignant tumors such as lung cancer, gastrointestinal cancer and bladder cancer, and provides scientific basis for precise treatment of malignant tumors.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location status: Recruiting

Location contact

Lei Yin, Dr.

CONTACT

[email protected]

+861083575252

About this study

This project uses HER2 protein as the target group of radiodrugs to explore the diagnostic efficacy, safety and metabolic characteristics of 68Ga-Her2-affibody in the expression status of HER2 in whole body cancer lesions, aiming to provide a new imaging method for the determination of HER2 status in breast cancer and supplement more overall information that is difficult to obtain by traditional core needle biopsy. At the same time, it also provides new methods and means for early diagnosis, accurate staging, recurrence judgment, treatment decision-making and prognosis judgment of malignant tumors such as lung cancer, gastrointestinal cancer and bladder cancer, and provides scientific basis for precise treatment of malignant tumors.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with confirmed or suspected cancer; Signed written informed consent

Exclusion criteria

-

Treatment and study plan

68Ga-Her2-affibody

Drug

68Ga-Her2-affibody is injected intravenously with a dose of 0.06-0.08 mCi/kg.

Other names: Her2 specific PET imaging

Primary outcomes

  1. The diagnostic efficacy of 68Ga-Her2-affibody PET/CT in the evaluation of breast cancer

    Time frame: 1 year

    the standardized Uptake Value (SUV) of lesions on 68Ga-Her2-affibody PET/CT

Secondary outcomes

  1. The dosimetry of 68Ga-Her2-affibody

    Time frame: 1 year

    Research on the dose distribution of 68Ga-Her2-affibody in cancer patients by 1-hour dynamic PET/CT acquisition and analyze by the dosimetry software

  2. Quantitative evaluation of 68Ga-Her2-affibody

    Time frame: 1 year

    Analyze Her2 expression at the imaging level in combination with Her2 expression

  3. Correlation with pathological expression

    Time frame: 1 year

    Analyze Her2 expression at the imaging level in combination with Her2 expression in pathological specimens

Study contacts

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

Lei Yin, Dr

CONTACT

[email protected]

+8610835725252

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

A Study to Evaluate 68Ga-Her2-affibody PET/CT Imaging of Her2 Expression in Tumors

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 4, 2024
Registry last updated
Dec 18, 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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