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NCT Number: NCT05593107

68Ga-N188 PET/CT Imaging in Malignancy

The Nectin-4 protein belongs to the cell adhesion factors family and has a tissue-specific expression spectrum in normal human tissues. However, Nectin-4 is overexpressed in various malignancies, especially those of epithelial origins, such as uroepithelial carcinoma, making Nectin-4 a highly specific and significant imaging target for malignancies.

[68Ga]N188, a novel molecular probe of PET imaging agent that targets Nectin-4, can be used in the diagnosis and research of a wide variety of Nectin-4 high-expression malignancies, including bladder cancer.

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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

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients with confirmed or suspected cancer;
  • 18F-FDG PET/CT within 1 week;
  • Signed written informed consent.

Exclusion criteria

  • Pregnant and lactating women;
  • Female patients plan to become pregnant within 6 months.

Treatment and study plan

[68Ga]N188

Drug

68Ga-N188 is injected intravenously with a dose of 0.06-0.08 mCi/kg.

Other names: 68Ga-N188, Nectin-4 specific PET imaging

Primary outcomes

  1. The diagnostic efficacy of 68Ga-N188 PET/CT in the evaluation of malignant tumors

    Time frame: 1 year

    Compare the standardized Uptake Value (SUV) of lesions on 68Ga-N188 and 18F-FDG PET/CT

  2. The diagnostic efficacy of 68Ga-N188 PET/CT in the evaluation of malignant tumors

    Time frame: 1 year

    Compare the number of lesions detected by 68Ga-N188 and 18F-FDG PET/CT, based on the pathology or clinical follow-up as gold standard.

Secondary outcomes

  1. The dosimetry of 68Ga-N188

    Time frame: 1 year

    Research on the dose distribution of 68Ga-N188 in healthy volunteers and cancer patients by 1-hour dynamic PET/CT acquisition and analyze by the dosimetry software

  2. Quantitative evaluation of 68Ga-N188

    Time frame: 1 year

    Evaluation of quantitative parameters of 68Ga-N188, such as time-activity curve.

  3. Correlation with pathological expression

    Time frame: 1 year

    Analyze Nectin-4 expression at the imaging level in combination with Nectin-4 expression in pathological specimens

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Official study title

A Study to Evaluate 68Ga-N188 PET/CT Imaging of Nectin-4 Expression in Malignant Tumors

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Oct 25, 2022
Registry last updated
Nov 21, 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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