Cancer of Unknown Primary SiteNCT07372963
18F-FAPI PET in Cancers of Unknown Primary Site
An observational study of Cancer of Unknown Primary Site, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
This study aims to evaluate the diagnostic efficacy, therapeutic assessment, prognostic analysis, and impact on clinical treatment decisions of 18F-FAPI PET/CT in patients with cancer of unknown primary. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Cancer of Unknown Primary Site
- What is being tested?
- 18F-FAPI PET
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 31 Dec 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 120
Who may be able to join
- Patients with clinical or imaging suspicion of cancer of unknown primary origin.
- Patients with 18F FAPI PET scans.
Who cannot join
- Concurrent presence of other active malignant tumors or a history of other malignant tumors within the past 5 years;
- Severe uncontrollable diseases or active infections;
- Ineligible participants for project informed consent.
- Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Donghe Chen, MD, 0571-87236431, chendonghe@zju.edu.cn
About this study
Official title: Prospective Clinical Study and Exploration of 18F-FAPI PET/CT Imaging in Cancers of Unknown Primary Site
This study aims to evaluate the diagnostic efficacy, therapeutic assessment, prognostic analysis, and impact on clinical treatment decisions of 18F-FAPI PET/CT in patients with cancer of unknown primary.
Read the detailed description
Primary endpoint: Diagnostic efficacy of 18F-FAPI PET/CT in patients with undetermined primary tumor (sensitivity, specificity, accuracy).
secondary end points:
- The diagnostic performance of 18F-FAPI PET/CT compared with CT, MR and 18F-FDG PET in the clinical application of cancer with unknown primary site was compared. ④Assess the heterogeneity of sensitivity and specificity of 18F-FAPI PET/CT for different system sites (neck/thorax/abdomen).
- Study on efficacy evaluation and prognostic prediction of 18F-FAPI PET/CT in patients with primary tumors of unknown origin.
- Conditions
- Cancer of Unknown Primary Site
- Being tested
- 18F-FAPI PET
- Medical subject headings
- Neoplasms, Unknown Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FAPI PETDiagnostic test
18F-FAPI-04 PET/CT
| Study group | Role | What they receive |
|---|---|---|
| FAPI-cups | FAPI PET scan in patients with CUPs Receives: Diagnostic Test: 18F-FAPI PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic efficacy
Sensitivity, specificity, positive and negative predictive value of 18F-FAPI PET/CT Imaging in cancers of unknown primary site
Measured: through study completion, an average of 1.5 year
Secondary outcomes (3)
Standard uptake value （SUV）of tumor
This measure evaluates the association between baseline 18F-FAPI PET parameters (e.g., SUVmax, SUVmean).
Measured: through study completion, 3-4 years
Metabolic tumor volume (c) and total lesion glycolysis (TLG) of tumor
This measure evaluates the association between baseline 18F-FAPI PET parameters (MTV in cm3, TLG in cm3*SUV）
Measured: through study completion, 3-4 years
Prognostic Value of Baseline 18F-FAPI PET for Progression-Free Survival (PFS) in High-Risk Patients
Prognostic Value of Baseline 18F-FAPI PET for Progression-Free Survival (PFS) in High-Risk Patients
Measured: through study completion, 3-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Unknown Primary SiteStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372963
- Sponsor's protocol ID
- FirstZhejiangU-FAPI-CUPs
- Status last verified
- Dec 2025
- First submitted
- 25 Dec 2025
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study and Exploration of 18F-FAPI PET/CT Imaging in Cancers of Unknown Primary Site
- ClinicalTrials.gov ID
- NCT07372963
- Acronym / sponsor ID
- FirstZhejiangU-FAPI-CUPs
- Conditions
- Cancer of Unknown Primary Site
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Jan 2026 (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 study aims to evaluate the diagnostic efficacy, therapeutic assessment, prognostic analysis, and impact on clinical treatment decisions of 18F-FAPI PET/CT in patients with cancer of unknown primary.
Detailed description
Primary endpoint: Diagnostic efficacy of 18F-FAPI PET/CT in patients with undetermined primary tumor (sensitivity, specificity, accuracy).
secondary end points:
- The diagnostic performance of 18F-FAPI PET/CT compared with CT, MR and 18F-FDG PET in the clinical application of cancer with unknown primary site was compared. ④Assess the heterogeneity of sensitivity and specificity of 18F-FAPI PET/CT for different system sites (neck/thorax/abdomen).
- Study on efficacy evaluation and prognostic prediction of 18F-FAPI PET/CT in patients with primary tumors of unknown origin.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FAPI-cups | – | Diagnostic Test: 18F-FAPI PETFAPI PET scan in patients with CUPs |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 120
Key inclusion criteria (2 listed)
- Patients with clinical or imaging suspicion of cancer of unknown primary origin.
- Patients with 18F FAPI PET scans.
Key exclusion criteria (4 listed)
- Concurrent presence of other active malignant tumors or a history of other malignant tumors within the past 5 years;
- Severe uncontrollable diseases or active infections;
- Ineligible participants for project informed consent.
- Pregnant and lactating women.
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 PET18F-FAPI-04 PET/CT | Diagnostic test | FAPI-cups |
Primary outcome
Diagnostic efficacy
Time frame: through study completion, an average of 1.5 year
Sensitivity, specificity, positive and negative predictive value of 18F-FAPI PET/CT Imaging in cancers of unknown primary site
3 secondary outcomes
Standard uptake value （SUV）of tumor
Time frame: through study completion, 3-4 years
Metabolic tumor volume (c) and total lesion glycolysis (TLG) of tumor
Time frame: through study completion, 3-4 years
Prognostic Value of Baseline 18F-FAPI PET for Progression-Free Survival (PFS) in High-Risk Patients
Time frame: through study completion, 3-4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Cancer of Unknown Primary Site, run by First Affiliated Hospital of 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 2 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: opening soon, as of the sponsor's last update on 28 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donghe Chen, MD (0571-87236432, chendonghe@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic efficacy (time frame: through study completion, an average of 1.5 year). 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 28 Jan 2026.