Pancreatic CancerEarly Phase 1NCT05875753
68Ga-FAPI-FS PET/CT and PET/MR in Pancreatic Cancer
A Early Phase 1 study testing 68Ga-FAPI-FS PET/CT in people with Pancreatic Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- 68Ga-FAPI-FS PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Jun 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pancreatic cancer confirmed by histopathological results or pancreatic lesions with typical radiological appearance.
- Expected survival of at least 3 months
- ECOG ≤ 2
- Written informed consent provided for participation in the trial
- In the opinion of investigator, willing and able to comply with required study procedures.
Who cannot join
- Pregnancy or breastfeeding.
- Severe claustrophobia.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Wenjia Zhu, MD, 18614080164, zhuwenjia_pumc@163.com
Li Huo, MD, 18612672038, huoli@pumch.cn
About this study
Official title: Preliminary Study of 68Ga-FAPI-FS PET/CT in Patients With 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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- 68Ga-FAPI-FS PET/CT
- Keywords
- 68Ga-FAPI-FS, PET/CT
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI-FS PET/CTDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-FAPI-FS PET/CT | Experimental | Each patient will receive one dose of 68Ga-FAPI-FS by intravenous route. Dedicated whole-body PET/CT imaging will be performed. Receives: Diagnostic Test: 68Ga-FAPI-FS PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events after injection of 68Ga-FAPI-FS
Adverse events will be recorded according to CTCEA v4.03
Measured: From tracer injection to 3 hour post-injection
Secondary outcomes (7)
SUVmax of liver on 68Ga-FAPI-FS
The liver uptake will be measured using SUVmax with a 40% threshold.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From study completion to 1 month after completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 Jun 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Huo, MD, Principal investigator, Peking Uion Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05875753
- Sponsor's protocol ID
- FAPI-FS
- Status last verified
- May 2023
- First submitted
- 16 May 2023
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study of 68Ga-FAPI-FS PET/CT in Patients With Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05875753
- Acronym / sponsor ID
- FAPI-FS
- Conditions
- Pancreatic Cancer
- Keywords
- 68Ga-FAPI-FS, PET/CT
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 25 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-FAPI-FS PET/CT | Experimental | Diagnostic Test: 68Ga-FAPI-FS PET/CTEach patient will receive one dose of 68Ga-FAPI-FS by intravenous route. Dedicated whole-body PET/CT imaging will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pancreatic cancer confirmed by histopathological results or pancreatic lesions with typical radiological appearance.
- Expected survival of at least 3 months
- ECOG ≤ 2
- Written informed consent provided for participation in the trial
- In the opinion of investigator, willing and able to comply with required study procedures.
Key exclusion criteria (2 listed)
- Pregnancy or breastfeeding.
- Severe claustrophobia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-FAPI-FS PET/CTParticipants 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. | Diagnostic test | 68Ga-FAPI-FS PET/CT |
Primary outcome
Adverse events after injection of 68Ga-FAPI-FS
Time frame: From tracer injection to 3 hour post-injection
Adverse events will be recorded according to CTCEA v4.03
7 secondary outcomes
SUVmax of liver on 68Ga-FAPI-FS
Time frame: From study completion to 1 month after completion
SUVmax of normal pancreas on 68Ga-FAPI-FS
Time frame: From study completion to 1 month after completion
SUVmax of blood pool on 68Ga-FAPI-FS
Time frame: From study completion to 1 month after completion
SUVmax of lung on 68Ga-FAPI-FS
Time frame: From study completion to 1 month after completion
SUVmax of brain on 68Ga-FAPI-FS
Time frame: From study completion to 1 month after completion
SUVmax of muscle on 68Ga-FAPI-FS
Time frame: From study completion to 1 month after completion
SUVmax of tumor lesions on 68Ga-FAPI-FS
Time frame: From study completion to 1 month after completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Huo, MD principal investigator
Peking Uion Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 68Ga-FAPI-FS PET/CT in people with Pancreatic Cancer, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Huo, MD (18612672038, huoli@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events after injection of 68Ga-FAPI-FS (time frame: From tracer injection to 3 hour post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2023.