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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
30
Each subject receive a single intravenous injection of 68Ga-DOTA-F2 and 18F-FDG, and undergo PET/CT imaging within the specified time.
Peking union medical college hospital
Beijing, Beijing Municipality, China
RECRUITINGStandardized uptake value (SUV)
Standardized uptake value (SUV) of 68Ga-DOTA-F2 and 18F-FDG for each primary tumor of subject or suspected lymph metastasis
Time frame: through study completion, an average of 1 year
Lession detection ability
Lession number detected by 68Ga-DOTA-F2 and 18F-FDG PET/CT
Time frame: through study completion, an average of 1 year
Sensitivity
The sensitivity of 68Ga-DOTA-F2 PET/CT and 18F-FDG PET/CT
Time frame: through study completion, an average of 1 year
Specificity
The specificity of 68Ga-DOTA-F2 PET/CT and 18F-FDG PET/CT
Time frame: through study completion, an average of 1 year
Radiation Dosimetry
Mean absorbed radiation doses were estimated using the source and target organ framework. Five patients with different cancers underwent serial 68Ga-DOTA-F2 PET/CT scans at five-time points following radiotracer injection: 5 minutes, 15 minutes, 30 minutes, 1 hour, and 3 hours. The source organs consisted of the kidneys, bladder, liver, heart, spleen, bone marrow, uterus, and body remainder. OLINDA/EXM software was used to fit and integrate the kinetic organ activity data to yield total body and organ time-integrated activity coefficients/residence times and finally organ absorbed doses.
Time frame: 30 days
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