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2022-06-01
2024-06-01
2024-06-01
50
NCT05875753
Peking Union Medical College Hospital
Peking Union Medical College Hospital
INTERVENTIONAL
68Ga-FAPI-FS PET/CT and PET/MR in Pancreatic Cancer
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-05-16 | N/A | 2023-05-16 |
2023-05-16 | N/A | 2023-05-25 |
2023-05-25 | N/A | 2023-05 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: 68Ga-FAPI-FS PET/CT Each patient will receive one dose of 68Ga-FAPI-FS by intravenous route. Dedicated whole-body PET/CT imaging will be performed. | DIAGNOSTIC_TEST: 68Ga-FAPI-FS PET/CT
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Adverse events after injection of 68Ga-FAPI-FS | Adverse events will be recorded according to CTCEA v4.03 | From tracer injection to 3 hour post-injection |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| SUVmax of liver on 68Ga-FAPI-FS | The liver uptake will be measured using SUVmax with a 40% threshold. | From study completion to 1 month after completion |
| SUVmax of normal pancreas on 68Ga-FAPI-FS | The normal pancreas uptake will be measured using SUVmax with a 40% threshold. | From study completion to 1 month after completion |
| SUVmax of blood pool on 68Ga-FAPI-FS | The blood pool uptake will be measured using SUVmax with a 40% threshold. | From study completion to 1 month after completion |
| SUVmax of lung on 68Ga-FAPI-FS | The lung uptake will be measured using SUVmax with a 40% threshold. | From study completion to 1 month after completion |
| SUVmax of brain on 68Ga-FAPI-FS | The brain uptake will be measured using SUVmax with a 40% threshold. | From study completion to 1 month after completion |
| SUVmax of muscle on 68Ga-FAPI-FS | The muscle will be measured using SUVmax with a 40% threshold. | From study completion to 1 month after completion |
| SUVmax of tumor lesions on 68Ga-FAPI-FS | The tumor lesions will be measured using SUVmax with a 40% threshold. | From study completion to 1 month after completion |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Li Huo, MD Phone Number: 18612672038 Email: huoli@pumch.cn |
Study Contact Backup Name: Wenjia Zhu, MD Phone Number: 18614080164 Email: zhuwenjia_pumc@163.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
