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NCT Number: NCT06688071

FAPI PET/CT in Various FAP-Related Disease Patients

To evaluate the potential usefulness of 68Ga/18F-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various FAP-related disease patients.

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Key information

Conditions

FAP-related Disease Metastasis Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Positron Emission Tomography Tumor

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location status: Recruiting

Location contact

Haonan Yu, MD

CONTACT

[email protected]

+8613821000597

Shaobo Yao, PhD

PRINCIPAL_INVESTIGATOR

About this study

Subjects with various FAP-related disease patients underwent 68Ga/18F-FAPI PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga/18F-FAPI PET/CT were calculated.

Who can participate

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

Inclusion criteria

  • (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled FAPI PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion criteria

  • (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Treatment and study plan

Single Group Assignment

Diagnostic Test

68Ga-DOTA/NOTA-FAPI-04 Each subject receive a single intravenous injection of 68Ga/18F-FAPI, and undergo PET/CT imaging within the specificed time.

Primary outcomes

  1. Standardized uptake value (SUV)

    Time frame: 30 days

    Standardized uptake value (SUV) of FAPI for each target lesion of subject or suspected primary tumor or/and metastasis.

Secondary outcomes

  1. Diagnostic efficacy

    Time frame: 30 days

    The sensitivity, specificity and accuracy of FAPI PET/CT were calculated.

Study contacts

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

Haonan Yu, MD

CONTACT

[email protected]

+8613821000597

Shaobo Yao, PhD

CONTACT

[email protected]

+8615122570279

Sponsors and collaborators

Lead sponsor

Tianjin Medical University

Other

Collaborators

  • Tianjin Medical University General Hospital

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Nov 14, 2024
Registry last updated
Feb 11, 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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