Tumor, Solid Clinical Trial
Official title:
Clinical Applications of Fibroblast Activation Protein Inhibitor-Based Dimeric Radiotracer 68Ga-DOTA-F2 PET/CT Imaging for Malignant Tumors
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | September 15, 2023 |
Est. primary completion date | September 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Peking union medical college hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Standardized uptake value (SUV) | Standardized uptake value (SUV) of 68Ga-DOTA-F2 and 18F-FDG for each primary tumor of subject or suspected lymph metastasis | through study completion, an average of 1 year | |
Primary | Lession detection ability | Lession number detected by 68Ga-DOTA-F2 and 18F-FDG PET/CT | through study completion, an average of 1 year | |
Secondary | Sensitivity | The sensitivity of 68Ga-DOTA-F2 PET/CT and 18F-FDG PET/CT | through study completion, an average of 1 year | |
Secondary | Specificity | The specificity of 68Ga-DOTA-F2 PET/CT and 18F-FDG PET/CT | through study completion, an average of 1 year | |
Secondary | 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. | 30 days |
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