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Trial Title:
68Ga-DOTA-F2 PET/CT in Patients With Various Types of Cancer
NCT ID:
NCT05637034
Condition:
Tumor, Solid
Conditions: Official terms:
Fluorodeoxyglucose F18
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
68Ga-DOTA-F2 PET/CT and 18F-FDG
Description:
Each subject receive a single intravenous injection of 68Ga-DOTA-F2 and 18F-FDG, and
undergo PET/CT imaging within the specified time.
Arm group label:
68Ga-DOTA-F2 PET/CT and 18F-FDG
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking union medical college hospital
Address:
City:
Beijing
Zip:
10010
Country:
China
Status:
Recruiting
Contact:
Last name:
Peipei Wang, MD
Phone:
18511395988
Email:
wpp199411@163.com
Contact backup:
Last name:
Fang Li, MD
Phone:
13901054627
Email:
lifang@pumch.cn
Start date:
September 15, 2022
Completion date:
September 15, 2023
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05637034
