18F-FAPI-RGD PET/CT in Various Tumor Types

Clinical Evaluation of 18F-FAPI-RGD PET/CT for Imaging of Fibroblast Activation Protein and Integrin avb3 in Various Tumor Types

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06094530

Enrollment

100

Registered

2023-10-23

Start date

2023-04-10

Completion date

2024-10-31

Last updated

2023-10-23

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

Conditions

Neoplasms

Brief summary

The clinical feasibility of 18F-FAPI-RGD PET/CT will be evaluated in 100 patients with various types of tumor, and the results will be compared with those of 18F-FDG.

Detailed description

The aim of this study is to evaluate, in patients with various types of tumor, the radiotracer uptake and clinical feasibility of 18F-FAPI-RGD PET/CT compared with those of 18F-FDG PET/CT. To evaluate the diagnostic performance of 18F-FAPI-RGD and 18F-FDG PET imaging, the results of the visually interpreted PET images will be compared with the histopathologic results (via surgery or biopsy), which are used as the gold standard for the ﬁnal diagnosis. For patients for whom tissue diagnosis is not applicable, clinical and radiographic follow-up data will be used as the reference standard to validate the PET/CT ﬁndings.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

10 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

* Patients with clinically suspected or diagnosed tumors

Exclusion criteria

* Hypertension that is difficult to control with medication, and systolic blood pressure exceeding 160mmHg * Complicated with chronic liver disease, myocardial infarction, stroke * Female patients who are pregnant (or attempting to become pregnant within six months), breastfeeding, or unwilling to use contraception * Abnormal cardiopulmonary function or mental state, unable to tolerate prone lying for 20 minutes

Design outcomes

Primary

Measure	Time frame	Description
Comparison of 18F-FAPI-RGD and 18F-FDG Uptake in Patients with different Tumors	1 month	Tracer uptake in normal organs (background) is quantiﬁed by SUVmean, which is delineated with a sphere that had a diameter of 1 cm (for small organs, including thyroid, salivary gland, and pancreas) to 2 cm(for other organs, including brain, heart, liver, kidney, spleen, muscle, and bone marrow) placed inside the organ parenchyma. The tumor-to background ratio (TBR) is calculated as tumor SUVmax/background SUVmean.

Countries

China

Contacts

Primary ContactHao Wang, Doctor

474556259@qq.com+86-18313820216

Outcome results