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18F-FAPI PET/CT in Patients With Various Types of Cancer

The Performance of 18F-FAPI PET/CT in Patients With Various Types of Cancer

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05810324
Enrollment
500
Registered
2023-04-12
Start date
2022-07-01
Completion date
2025-01-01
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Brief summary

To evaluate the potential usefulness of 18F-FAPI positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer.

Detailed description

Subjects with various types of cancer underwent 18F-FAPI PET/CT either for an initial assessment or for recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). Using histopathology and follow-up as gold standard, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FAPI PET/CT were calculated.

Interventions

Each patient receive a single intravenous injection of 18F-FAPI, and undergo PET/CT scan within specified time.

Sponsors

Jilin University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); * patients who had scheduled 18F-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

* patients with non-malignant lesions; * patients with pregnancy; * the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy1 yearThe sensitivity, specificity and accuracy of 18F-FAPI PET/CT were calculated.

Countries

China

Contacts

Primary ContactShi Gao
Gaoshi@jlu.edu.cn+86-0431-84995467

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026