Gastrointestinal CancerNCT05788874
Study of 18F-FAPI Applied to Gastrointestinal Cancer
An observational study of Gastrointestinal Cancer, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial summary
Comparison of tumor volume, number, and SUVmax of different primary foci (gastric, duodenal, and colon cancer), lymph node metastases (neck and supraclavicular, mediastinal, abdominal, and pelvic), and distant metastases (brain, lung, liver, bone, pleura, and peritoneum) detected by 18F-FAPI versus 18F-FDG PET/CT… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Cancer
- What is being tested?
- 18F-FAPI and 18F-FDG PET/CT
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2023to Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Patients with high clinical suspicion of gastrointestinal tumor and negative 18F-FDG at first diagnosis * Post-treatment patients with high clinical suspicion of recurrence or metastasis and negative 18F-FDG
Who may be able to join
- Patients with high clinical suspicion of gastrointestinal tumor and negative 18F-FDG at first diagnosis
- Post-treatment patients with high clinical suspicion of recurrence or metastasis and negative 18F-FDG
Who cannot join
- The diagnosis can be clarified by 18F-FDG PET/CT examination
- The presence of recurrence or metastasis can be clarified by 18F-FDG PET/CT examination
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study of 18F-FAPI and 18F-FDG PET/CT for Gastrointestinal Cancer
Comparison of tumor volume, number, and SUVmax of different primary foci (gastric, duodenal, and colon cancer), lymph node metastases (neck and supraclavicular, mediastinal, abdominal, and pelvic), and distant metastases (brain, lung, liver, bone, pleura, and peritoneum) detected by 18F-FAPI versus 18F-FDG PET/CT imaging.
- Conditions
- Gastrointestinal Cancer
- Being tested
- 18F-FAPI and 18F-FDG PET/CT
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FAPI and 18F-FDG PET/CTDiagnostic test
18F-FAPI and 18F-FDG PET/CT for gastrointestinal cancer
| Study group | Role | What they receive |
|---|---|---|
| 18F-FDG | Not described Receives: Diagnostic Test: 18F-FAPI and 18F-FDG PET/CT | |
| 18F-FAPI | Not described Receives: Diagnostic Test: 18F-FAPI and 18F-FDG PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVmax
Measurement of the maximum standardized uptake value of the lesion
Measured: 1 day (During the inspection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study startMay 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788874
- Sponsor's protocol ID
- XJTU1AF-CRF-2022-021
- Status last verified
- Apr 2023
- First submitted
- 16 Mar 2023
- Last updated
- 14 Apr 2023
- 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 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of 18F-FAPI and 18F-FDG PET/CT for Gastrointestinal Cancer
- ClinicalTrials.gov ID
- NCT05788874
- Acronym / sponsor ID
- XJTU1AF-CRF-2022-021
- Conditions
- Gastrointestinal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 29 Mar 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.
Comparison of tumor volume, number, and SUVmax of different primary foci (gastric, duodenal, and colon cancer), lymph node metastases (neck and supraclavicular, mediastinal, abdominal, and pelvic), and distant metastases (brain, lung, liver, bone, pleura, and peritoneum) detected by 18F-FAPI versus 18F-FDG PET/CT imaging.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 18F-FDG | – | Diagnostic Test: 18F-FAPI and 18F-FDG PET/CT |
| 18F-FAPI | – | Diagnostic Test: 18F-FAPI and 18F-FDG PET/CT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Patients with high clinical suspicion of gastrointestinal tumor and negative 18F-FDG at first diagnosis * Post-treatment patients with high clinical suspicion of recurrence or metastasis and negative 18F-FDG
Key inclusion criteria (2 listed)
- Patients with high clinical suspicion of gastrointestinal tumor and negative 18F-FDG at first diagnosis
- Post-treatment patients with high clinical suspicion of recurrence or metastasis and negative 18F-FDG
Key exclusion criteria (2 listed)
- The diagnosis can be clarified by 18F-FDG PET/CT examination
- The presence of recurrence or metastasis can be clarified by 18F-FDG PET/CT examination
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 and 18F-FDG PET/CT18F-FAPI and 18F-FDG PET/CT for gastrointestinal cancer | Diagnostic test | 18F-FAPI, 18F-FDG |
Primary outcome
SUVmax
Time frame: 1 day (During the inspection)
Measurement of the maximum standardized uptake value of the lesion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Cancer, run by First Affiliated Hospital Xi'an Jiaotong University.
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 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 14 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Li (0086-15829364429, 29396779@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVmax (time frame: 1 day (During the inspection)). 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 14 Apr 2023.