18F-FAPINCT06277206
A Study Using 18F-FAPI PET to Evaluate Treatment Response in Pancreatic Adenocarcinoma
An observational study of 18F-FAPI and Pancreas Adenocarcinoma, run by Zhejiang University at 1 site in China.
Trial summary
To explore the potential utility of 18F-FAPI-04 PET/CT for pathologic response evaluation to systemic treatment in PDAC Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- 18F-FAPI, Pancreas Adenocarcinoma, Systemic Treatment
- What is being tested?
- 18F-FAPI PET/CT
- How many people
- 59 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2021to 10 Feb 2024
- Phase
- Observational
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pancreatic cancer patients with resectable, borderline or locally advanced disease who plan to undergo systemic treatment, including chemotherpy or chemoimmunotherapy
Who may be able to join
- suspected to have pancreatic cancer by radiological imaging
- planned systemic treatment
- possibility of conversion surgery
- willingness to participate the study
Who cannot join
- without pathologically confirmed pancreatic cancer
- poor performance status or organ functions that cannot meet the systemic treatment requirements
- metastatic disease
- pregnant patients
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital, Medical College of Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
Official title: A Study Using 18F-FAPI PET to Evaluate Pathologic Response to Systemic Treatment in Pancreatic Adenocarcinoma
To explore the potential utility of 18F-FAPI-04 PET/CT for pathologic response evaluation to systemic treatment in PDAC
- Being tested
- 18F-FAPI PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FAPI PET/CTDiagnostic test
Enrolled patients underwent 18F-FAPI PET/CT at diagnosis. And preoperative 18F-FAPI PET/CT was completed in the patients met the criteria for conversion surgery after systemic treatment. The correlation between changes of parameters before and after treatment and pathologic response was analyzed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Maximum standardized uptake value
Change of SUVmax before and after treatment
Measured: Baseline and preoperation
Change of Mean standardized uptake value
Change of SUVmean before and after treatment
Measured: Baseline and preoperation
Secondary outcomes (6)
Maximum standardized uptake value
Baseline SUVmax at diagnosis
Measured: Baseline
Mean standardized uptake value
Baseline SUVmean at diagnosis
Measured: Baseline
Metabolic Tumor Volume
Baseline MTV at diagnosis
Measured: Baseline
Total Lesion FAP expression
Baseline TLF at diagnosis
Measured: Baseline
Change of Metabolic Tumor Volume
Change of MTV before and after treatment
Measured: Baseline and preoperation
Change of Total Lesion FAP expression
Change of TLF before and after treatment
Measured: Baseline and preoperation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start4 Aug 2021
- Primary completion19 Nov 2023
- Study completion10 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 18F-FAPIStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277206
- Sponsor's protocol ID
- FAPIPDAC02
- Status last verified
- Feb 2024
- First submitted
- 17 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- 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 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Using 18F-FAPI PET to Evaluate Pathologic Response to Systemic Treatment in Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06277206
- Acronym / sponsor ID
- FAPIPDAC02
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 19 Nov 2023 (actual)
- Study completion
- 10 Feb 2024 (actual)
- First posted
- 26 Feb 2024 (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.
To explore the potential utility of 18F-FAPI-04 PET/CT for pathologic response evaluation to systemic treatment in PDAC
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pancreatic cancer patients with resectable, borderline or locally advanced disease who plan to undergo systemic treatment, including chemotherpy or chemoimmunotherapy
Key inclusion criteria (4 listed)
- suspected to have pancreatic cancer by radiological imaging
- planned systemic treatment
- possibility of conversion surgery
- willingness to participate the study
Key exclusion criteria (4 listed)
- without pathologically confirmed pancreatic cancer
- poor performance status or organ functions that cannot meet the systemic treatment requirements
- metastatic disease
- pregnant patients
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 |
|---|---|---|
| 18F-FAPI PET/CTEnrolled patients underwent 18F-FAPI PET/CT at diagnosis. And preoperative 18F-FAPI PET/CT was completed in the patients met the criteria for conversion surgery after systemic treatment. The correlation between changes of parameters before and after treatment and pathologic response was analyzed. | Diagnostic test | – |
Primary outcome
Change of Maximum standardized uptake value
Time frame: Baseline and preoperation
Change of SUVmax before and after treatment
Change of Mean standardized uptake value
Time frame: Baseline and preoperation
Change of SUVmean before and after treatment
6 secondary outcomes
Maximum standardized uptake value
Time frame: Baseline
Mean standardized uptake value
Time frame: Baseline
Metabolic Tumor Volume
Time frame: Baseline
Total Lesion FAP expression
Time frame: Baseline
Change of Metabolic Tumor Volume
Time frame: Baseline and preoperation
Change of Total Lesion FAP expression
Time frame: Baseline and preoperation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Individual participant dataSharing planned: No
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RecruitingPhase 3
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RecruitingPhase 3
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Enrolling by invitationObservational study
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 18F-FAPI and Pancreas Adenocarcinoma, run by Zhejiang University 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 26 Feb 2024. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Maximum standardized uptake value (time frame: Baseline and preoperation). The study lists 2 primary outcomes in all. 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 26 Feb 2024.