18F-FAPI-04 PET/CT and PET/MR in Patients With Various Types of Malignant Tumors

Preliminary Study on the Diagnostic Value of 18F-FAPI-04 PET/CT and PET/MR in Patients With Various Types of Malignant Tumors

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06557590

Enrollment

500

Registered

2024-08-16

Start date

2024-01-01

Completion date

2028-12-31

Last updated

2024-08-16

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

Conditions

Cancer, FAP

Brief summary

To evaluate the potential usefulness of 18F-FAPI-04 positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance imaging （PET/MR）for the diagnosis of primary and metastatic lesions, detection of recurrence or assessment of pathologic response in various types of cancer.

Detailed description

Subjects with various types of cancer underwent 18F-FAPI-04 PET/CT and PET/MR imaging either for an initial assessment, recurrence detection or assessment of pathologic response. Tumor uptake was quantified by the maximum standard uptake value (SUVmax) and tumor to background (TBR). Using histopathology and follow-up as gold standard, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FAPI-04 PET/CT and PET/MR were calculated.

Interventions

DIAGNOSTIC_TEST18F-FAPI-04

18F-FAPI-04 was injected into the patients before the PET/CT or PET/MR scans

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Yes

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 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

Measure	Time frame	Description
Diagnostic Performance	1 year	Diagnostic accuracy, The sensitivity, specificity and accuracy of 18F-FAPI-04 PET/CT and PET/MR were calculated.

Countries

China

Contacts

Primary ContactHui Ye, PhD

yehui@hnca.org.cn13755117105

Outcome results

None listed

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