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Trial Title:
68Ga-FAPI-FS PET/CT and PET/MR in Pancreatic Cancer
NCT ID:
NCT05875753
Condition:
Pancreatic Cancer
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
68Ga-FAPI-FS
PET/CT
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
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-FAPI-FS PET/CT
Description:
Participants will be administered a single, intravenous bolus of 68Ga-FAPI-FS. The
recommended administered activity of 68Ga-NY104 is 1.8-2.2 MBq per kilogram bodyweight,
subject to variation that may be required owing to variable elution efficiencies obtained
during the lifetime of the 68Ga / 68Ga generator.
The CT and PET imaging session will begin approximately 45 to 75 minutes after
68Ga-FAPI-FS administration.
Arm group label:
68Ga-FAPI-FS PET/CT
Summary:
This is a preliminary study of 68Ga-FAPI-FS PET/CT or PET/MR in patients with confirmed
or suspicious pancreatic cancer. The goal is to determine the safety, biodistribution,
and tumor uptake of 68Ga-FAPI-FS.
Detailed description:
This is a preliminary phase 0 study in patients with confirmed or suspicious pancreatic
cancer. Each patient will receive one dose of 68Ga-FAPI-FS by intravenous route.
Dedicated whole-body PET/CT imaging will be performed. A comparative 18F-FDG PET/CT will
also be performed within a week.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Pancreatic cancer confirmed by histopathological results or pancreatic lesions with
typical radiological appearance.
2. Expected survival of at least 3 months
3. ECOG ≤ 2
4. Written informed consent provided for participation in the trial
5. In the opinion of investigator, willing and able to comply with required study
procedures.
Exclusion Criteria:
1. Pregnancy or breastfeeding.
2. Severe claustrophobia.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking Union Medical College Hospital
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenjia Zhu, MD
Phone:
18614080164
Email:
zhuwenjia_pumc@163.com
Contact backup:
Last name:
Li Huo, MD
Phone:
18612672038
Email:
huoli@pumch.cn
Start date:
June 1, 2022
Completion date:
June 1, 2024
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/NCT05875753
