18F-FAPINCT05884463
18F-FAPI PET Imaging in Pancreatic Adenocarcinoma
A study testing 18F-FAPI and 18F-FDG in people with 18F-FAPI and 18F-FDG, run by Zhejiang University at 1 site in China.
Trial summary
To explore the potential efficacy of 18F-FAPI-04 PET/CT for PDAC tumour staging and compare the results with those obtained using 18F-FDG PET/CT. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- 18F-FAPI, 18F-FDG, Pancreas Adenocarcinoma
- What is being tested?
- 18F-FAPI and 18F-FDG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 28 Feb 2023
- Phase
- Interventional
- 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
Who may be able to join
- patients who were suspected to have PDAC by radiological imaging patients who underwent paired 18F-FAPI-04 PET/CT and 18F-FDG PET/CT for metastasis screening, recurrence confirmation, or tumour staging patients who were willing to participate in clinical trials and signed an informed consent form.
Who cannot join
- patients with a history of severe contrast allergy pregnant patients patients who were not pathologically diagnosed as showing PDAC.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
About this study
Official title: 18F-FAPI PET/CT and 18F-FDG PET/CT in Patients With Pancreatic Adenocarcinoma : A Prospective, Single-Center, Comparative Study
To explore the potential efficacy of 18F-FAPI-04 PET/CT for PDAC tumour staging and compare the results with those obtained using 18F-FDG PET/CT.
Read the detailed description
Accurate diagnosis and staging are crucial for selecting treatment for patients with pancreatic ductal adenocarcinoma (PDAC). The desmoplastic responses associated with PDAC are often characterised by hypometabolism. Here we investigated 18F-fibroblast activation protein inhibitor (18F-FAPI-04) positron emission tomography/computed tomography (PET/CT) in evaluation of PDAC, and compared the findings with those obtained using (18F)-fluorodeoxyglucose (18F-FDG).
- Conditions
- 18F-FAPI, 18F-FDG, Pancreas Adenocarcinoma, Diagnosis, Staging
- Being tested
- 18F-FAPI, 18F-FDG
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FAPIDrug
Also called (18)F-FAPI
Intravenous injection of one dosage of 18F-FAPI.
18F-FDGDrug
Also called (18)F-FDG
Intravenous injection of one dosage of 18F-FDG.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients underwent both 18F-FDG PET/CT and 18F-FDG PET/CT scan Receives: Drug: 18F-FAPI; Drug: 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic value
Sensitivity and Specificity of 18F-FAPI PET/CT for diagnosis and staging in comparison with 18F-FDG PET/CT
Measured: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
Maximum standardized uptake value
SUVmax of 18F-FAPI PET/CT for lesions in comparison with 18F-FDG PET/CT
Measured: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
Secondary outcomes (5)
Diagnostic efficacy for primary lesions
Sensitivity, specificity, accuracy of 18F-FAPI PET/CT for primary lesions in comparison with 18F-FDG PET/CT
Measured: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
SUVmax for primary lesions
SUVmax of 18F-FAPI PET/CT for primary lesions in comparison with 18F-FDG PET/CT
Measured: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
SUVmax for lymph node
SUVmax of 18F-FAPI PET/CT for lymph node in comparison with 18F-FDG PET/CT
Measured: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
SUVmax for distant metastasis
SUVmax of 18F-FAPI PET/CT for distant metastasis in comparison with 18F-FDG PET/CT
Measured: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
Correlation between the SUVmax of 18F-FAPI and 18F-FDG uptake in patients with different treatment response
The correlation of SUVmax and treatment response
Measured: at least 2 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Apr 2021
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 18F-FAPIStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
- Investigators
- Tingbo Liang, Ph.D., M.D., Study director, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884463
- Sponsor's protocol ID
- FAPIPDAC01
- Status last verified
- May 2023
- First submitted
- 22 May 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li X, Lu N, Lin L, Chen Y, Yang S, Wang H, Liu X, Wu C, Xue X, Su X, Bai X, Liang T. 18F-FAPI-04 Outperforms 18F-FDG PET/CT in Clinical Assessments of Patients with Pancreatic Adenocarcinoma. J Nucl Med. 2024 Feb 1;65(2):206-212. doi: 10.2967/jnumed.123.266283.
PubMed 38176719
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-FAPI PET/CT and 18F-FDG PET/CT in Patients With Pancreatic Adenocarcinoma : A Prospective, Single-Center, Comparative Study
- ClinicalTrials.gov ID
- NCT05884463
- Acronym / sponsor ID
- FAPIPDAC01
- Conditions
- 18F-FAPI, 18F-FDG, Pancreas Adenocarcinoma, Diagnosis, Staging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 1 Jun 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.
To explore the potential efficacy of 18F-FAPI-04 PET/CT for PDAC tumour staging and compare the results with those obtained using 18F-FDG PET/CT.
Detailed description
Accurate diagnosis and staging are crucial for selecting treatment for patients with pancreatic ductal adenocarcinoma (PDAC). The desmoplastic responses associated with PDAC are often characterised by hypometabolism. Here we investigated 18F-fibroblast activation protein inhibitor (18F-FAPI-04) positron emission tomography/computed tomography (PET/CT) in evaluation of PDAC, and compared the findings with those obtained using (18F)-fluorodeoxyglucose (18F-FDG).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: 18F-FAPI, Drug: 18F-FDGPatients underwent both 18F-FDG PET/CT and 18F-FDG PET/CT scan |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients who were suspected to have PDAC by radiological imaging patients who underwent paired 18F-FAPI-04 PET/CT and 18F-FDG PET/CT for metastasis screening, recurrence confirmation, or tumour staging patients who were willing to participate in clinical trials and signed an informed consent form.
Key exclusion criteria (1 listed)
- patients with a history of severe contrast allergy pregnant patients patients who were not pathologically diagnosed as showing PDAC.
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-FAPIAlso: (18)F-FAPIIntravenous injection of one dosage of 18F-FAPI. | Drug | Experimental |
| 18F-FDGAlso: (18)F-FDGIntravenous injection of one dosage of 18F-FDG. | Drug | Experimental |
Primary outcome
Diagnostic value
Time frame: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
Sensitivity and Specificity of 18F-FAPI PET/CT for diagnosis and staging in comparison with 18F-FDG PET/CT
Maximum standardized uptake value
Time frame: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
SUVmax of 18F-FAPI PET/CT for lesions in comparison with 18F-FDG PET/CT
5 secondary outcomes
Diagnostic efficacy for primary lesions
Time frame: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
SUVmax for primary lesions
Time frame: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
SUVmax for lymph node
Time frame: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
SUVmax for distant metastasis
Time frame: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)
Correlation between the SUVmax of 18F-FAPI and 18F-FDG uptake in patients with different treatment response
Time frame: at least 2 months after treatment
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 1 Jun 2023.
- Derived from this study: PubMed 38176719Li X, Lu N, Lin L, Chen Y, Yang S, Wang H, Liu X, Wu C, Xue X, Su X, Bai X, Liang T. 18F-FAPI-04 Outperforms 18F-FDG PET/CT in Clinical Assessments of Patients with Pancreatic Adenocarcinoma. J Nucl Med. 2024 Feb 1;65(2):206-212. doi: 10.2967/jnumed.123.266283.
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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.
Tingbo Liang, Ph.D., M.D. study director
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 18F-FAPI and 18F-FDG in people with 18F-FAPI and 18F-FDG, 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 1 inclusion and 1 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 1 Jun 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.
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?
Diagnostic value (time frame: 1 day (At the time the patient has underwent both 18F-FAPI and 18F-FDG PET/CT)). 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?
On the ClinicalTrials.gov record for NCT05884463, which also lists 1 linked publication.
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 1 Jun 2023.