Clinical trial NCT05637034: 68Ga-DOTA-F2 PET/CT in Patients With Various Types of Cancer
Official title: Clinical Applications of Fibroblast Activation Protein Inhibitor-Based Dimeric Radiotracer 68Ga-DOTA-F2 PET/CT Imaging for Malignant Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tumor, Solid
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

1. Subject is aged 18 years or older
2. Signed Informed Consent
3. Subject is pathologically confirmed with a malignant tumor
4. Subject is judged to be in good general condition by the investigator based on medical history, physical examination including vital signs and clinical laboratory tests, besides the diagnosis of malignant tumor
5. Female subjects should be post-menopausal or surgically sterile or using effective contraceptive with the negative pregnancy test

Exclusion Criteria:

1. Subject has a previous or ongoing recurrent or chronic disease, other than malignant tumor, at high risk to interfere with the evaluation of the trial according to the judgment of the investigator
2. Subject with non-malignant lesions;
3. Subject with the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
4. Subject is potentially pregnant (serum and urinary hCG test will be performed in women where pregnancy is not excluded) or is breast-feeding

Primary outcomes:
measure: Standardized uptake value (SUV)
timeFrame: through study completion, an average of 1 year
measure: Lession detection ability
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Sensitivity
timeFrame: through study completion, an average of 1 year
measure: Specificity
timeFrame: through study completion, an average of 1 year
measure: Radiation Dosimetry
timeFrame: 30 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking union medical college hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Fang Li, MD
role: PRINCIPAL_INVESTIGATOR
References: