68Ga-DOTA-F2 PET/CT in Patients With Various Types of Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Enrolling

Conditions: Tumor, Solid

Treatments: Diagnostic Test: 68Ga-DOTA-F2 PET/CT and 18F-FDG

Study type: Interventional

Funder types: Other

Identifiers

NCT05637034

I-22PJ292

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

68Ga-DOTA-F2 PET/CT and 18F-FDG

Experimental group

Description:

Each subject receive a single intravenous injection of 68Ga-DOTA-F2 and 18F-FDG, and undergo PET/CT imaging within the specified time.

Treatment:

Diagnostic Test: 68Ga-DOTA-F2 PET/CT and 18F-FDG