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NCT Number: NCT06684028

PET Image Exploration of Novel Tracer [68Ga]-FAPI-JNU Imaging Studies in Patients with Malignant Tumors

To investigate the biological distribution of a new tracer 68Ga-FAPI-JNU in the primary, metastatic and normal tissues of patients with malignant tumors, and to evaluate the biological distribution of 68GA-FAPI-JNU with standardized uptake values.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiated Hospital of Jiangnan University

Wuxi, Jiangsu, 214000, China

Location status: Recruiting

Location contact

Chunjing Yu

CONTACT

[email protected]

15312238622

About this study

PET/CT imaging was performed about 1 hour after the patient was injected with the novel tracer 68Ga-FAPI-JNU. SUVmax and SUVmean values of the area of interest were mapped by two diagnostic physicians with more than 5 years of experience after the imaging was completed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The subjects sign the informed consent voluntarily and can complete the test according to the protocol requirements;
  • Age 18-85 years old, male or female;
  • Clinically diagnosed as malignant tumor, diagnostic criteria refer to biopsy or other imaging such as CT and MRI;
  • ECOG score is 0-3 points;

Exclusion criteria

  • Patients with a history or allergic constitution to any component of the developer, including alcohol;
  • pregnant or lactating women;
  • Patients with mental illness or related history;
  • Patients who cannot or cannot undergo a PET/CT scan;

Treatment and study plan

68Ga-FAPI-JNU

Drug

Patients will receive the novel tracer 68Ga-FAPI-JNU dose of approximately 2-5 mCi per person

Primary outcomes

  1. Evaluation of the distribution of 68Ga-FAPI-JNU in tumors, metastases and normal tissues

    Time frame: 4 hour

    CT and PET scans were performed on the patients injected with 68Ga-FAPI-JNU. After image reconstruction and PET/CT image fusion, the biological distribution of 68Ga-FAPI-JNU in the primary tumor, metastatic tumor and various tissues and organs of the patients was evaluated by radioactive uptake value (standardized uptake value, SUV)

Study contacts

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

chunjing Yu

CONTACT

[email protected]

15312238622

Sponsors and collaborators

Lead sponsor

Affiliated Hospital of Jiangnan University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
Jan 22, 2025

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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