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Completed

NCT Number: NCT05884463

18F-FAPI PET Imaging in Pancreatic Adenocarcinoma

To explore the potential efficacy of 18F-FAPI-04 PET/CT for PDAC tumour staging and compare the results with those obtained using 18F-FDG PET/CT.

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Key information

Conditions

18F-FAPI 18F-FDG Diagnosis Disease Pancreas Adenocarcinoma Pathologic Processes Pathological Conditions, Signs and Symptoms Staging

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

About this study

Accurate diagnosis and staging are crucial for selecting treatment for patients with pancreatic ductal adenocarcinoma (PDAC). The desmoplastic responses associated with PDAC are often characterised by hypometabolism. Here we investigated 18F-fibroblast activation protein inhibitor (18F-FAPI-04) positron emission tomography/computed tomography (PET/CT) in evaluation of PDAC, and compared the findings with those obtained using (18F)-fluorodeoxyglucose (18F-FDG).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

patients who were suspected to have PDAC by radiological imaging patients who underwent paired 18F-FAPI-04 PET/CT and 18F-FDG PET/CT for metastasis screening, recurrence confirmation, or tumour staging patients who were willing to participate in clinical trials and signed an informed consent form.

Exclusion criteria

patients with a history of severe contrast allergy pregnant patients patients who were not pathologically diagnosed as showing PDAC.

Treatment and study plan

18F-FAPI

Drug

Intravenous injection of one dosage of 18F-FAPI.

Other names: (18)F-FAPI

18F-FDG

Drug

Intravenous injection of one dosage of 18F-FDG.

Other names: (18)F-FDG

Primary outcomes

  1. Diagnostic value

    Time frame: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)

    Sensitivity and Specificity of 18F-FAPI PET/CT for diagnosis and staging in comparison with 18F-FDG PET/CT

  2. Maximum standardized uptake value

    Time frame: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)

    SUVmax of 18F-FAPI PET/CT for lesions in comparison with 18F-FDG PET/CT

Secondary outcomes

  1. Diagnostic efficacy for primary lesions

    Time frame: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)

    Sensitivity, specificity, accuracy of 18F-FAPI PET/CT for primary lesions in comparison with 18F-FDG PET/CT

  2. SUVmax for primary lesions

    Time frame: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)

    SUVmax of 18F-FAPI PET/CT for primary lesions in comparison with 18F-FDG PET/CT

  3. SUVmax for lymph node

    Time frame: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)

    SUVmax of 18F-FAPI PET/CT for lymph node in comparison with 18F-FDG PET/CT

  4. SUVmax for distant metastasis

    Time frame: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)

    SUVmax of 18F-FAPI PET/CT for distant metastasis in comparison with 18F-FDG PET/CT

  5. Correlation between the SUVmax of 18F-FAPI and 18F-FDG uptake in patients with different treatment response

    Time frame: at least 2 months after treatment

    The correlation of SUVmax and treatment response

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

18F-FAPI PET/CT and 18F-FDG PET/CT in Patients With Pancreatic Adenocarcinoma : A Prospective, Single-Center, Comparative Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 1, 2023
Registry last updated
Jun 1, 2023

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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