FAPI PET/CT in Various FAP-Related Disease Patients

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06688071

Enrollment

500

Registered

2024-11-14

Start date

2022-03-01

Completion date

2027-10-01

Last updated

2025-02-11

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

Conditions

FAP-related Disease, Tumor, Positron Emission Tomography, Metastasis

Keywords

PET/CT, FAP, FAPI

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTSingle Group Assignment

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Standardized uptake value (SUV)	30 days	Standardized uptake value (SUV) of FAPI for each target lesion of subject or suspected primary tumor or/and metastasis.

Secondary

Measure	Time frame	Description
Diagnostic efficacy	30 days	The sensitivity, specificity and accuracy of FAPI PET/CT were calculated.

Countries

China

Contacts

Primary ContactHaonan Yu, MD

dreamadam@126.com+8613821000597

Backup ContactShaobo Yao, PhD

yaoshaobo008@163.com+8615122570279

Outcome results

None listed

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