Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
Study NCT ID:
NCT05637034
Status:
UNKNOWN
Last Update Posted:
2022-12-05
First Post:
2022-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
68Ga-DOTA-F2 PET/CT in Patients With Various Types of Cancer
Sponsor:
Peking Union Medical College Hospital
Organization:
Study Overview
Official Title:
Clinical Applications of Fibroblast Activation Protein Inhibitor-Based Dimeric Radiotracer 68Ga-DOTA-F2 PET/CT Imaging for Malignant Tumors
Status:
UNKNOWN
Status Verified Date:
2022-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the potential usefulness of 68Ga-DOTA-F2 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various types of cancer, compared with 18F-FDG PET/CT.
Detailed Description:
Quinoline-based fibroblast activation protein (FAP) inhibitors (FAPIs; e.g., FAPI-04 and FAPI-46), which have shown promising results in the diagnosis of cancer and various other diseases in recent years, have become the focus of much productive research. Despite this, one major issue is that these FAPI molecules have a relatively short tumor retention time, which may limit their use in targeted radionuclide therapy applications. As a result, 68Ga-DOTA-F2, a novel dimeric FAPI molecule, was developed to increase tracer uptake and retention in tumors for potential therapeutic or theranostic applications. In preclinical study, 68Ga-DOTA-F2 has shown better tumor uptake and longer tumor retention time than 68Ga-FAPI in mouse tumor models. Our study will assess image quality and evaluate the diagnostic performance of 68Ga-DOTA-F2. Patients with histologically confirmed malignant tumors will be prospectively recruited in this study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: