To hear about similar clinical trials, please enter your email below
Trial Title:
Tracer Targeting FAP PET Imaging in Patients
NCT ID:
NCT05691894
Condition:
Cancer
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
18F-FAPI
Description:
Patients will receive a tracer dose of 18F (8-10mCi) labelled FAPI
Arm group label:
18F-FAPI
Intervention type:
Drug
Intervention name:
68Ga-FAPI
Description:
Patients will receive a tracer dose of 68Ga (2-5mCi) labelled FAPI
Arm group label:
68Ga-FAPI
Summary:
This is a single arm study to evaluate the safety and biodistribution of tracer targeting
FAP PET Imaging in patients
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients voluntarily signed informed consent;
2. Age 18-75, male or female;
3. Patients diagnosed with cancer confirmed by histopathology or cytology;
4. At least one measurable solid lesion has been examined according RECIST1.1 standard;
5. ECOG score 0~2.
Exclusion Criteria:
1. Recovery from major trauma (including surgery) within 4 weeks prior to study
treatment;
2. Patients with systemic or locally severe infections, or other serious coexisting
diseases;
3. Patients with abnormal immune function or who have recently used immunosuppressive
or potentiating agents including various vaccines;
4. Patients with autoimmune diseases, including rheumatoid arthritis;
5. Inadequate control of arrhythmias, including atrial fibrillation;
6. Uncontrolled hypertension;
7. Patients with allergies or allergies to any component of the imaging agent or
antibody;
8. Patients who cannot undergo PET/CT imaging scan;
9. Syphilis, HBV, HCV, or HIV positive subjects;
10. Male and female subjects of reproductive age cannot take effective contraceptive
measures;
11. Pregnant or lactating women;
12. Patients with a history of mental illness or related conditions;
13. Other subjects considered unsuitable by researchers.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated Hospital of Jiangnan University
Address:
City:
Wuxi
Zip:
214000
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunjing Yu
Phone:
15312238622
Email:
ycj_wxd1978@163.com
Start date:
November 2, 2022
Completion date:
November 2023
Lead sponsor:
Agency:
Affiliated Hospital of Jiangnan University
Agency class:
Other
Source:
Affiliated Hospital of Jiangnan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05691894
