Gastric CancerNCT06543108
Preliminary Study on the Diagnostic Value Comparison of 18F-FAPI-04 PET/CT and PET/MR in Gastric Cancer
An observational study of Gastric Cancer, run by Hunan Cancer Hospital at 1 site in China.
Trial summary
This project aims to comprehensively analyze the diagnostic efficacy of SUVmax, SUVean, TLG, MTV, etc. in gastric cancer through 18F-FAPI-04 PET/CT imaging combined with serum tumor markers and other methods, and construct a molecular imaging diagnostic model for gastric cancer; Next, analyze the diagnostic efficacy… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- The clinical value of 18F-FAPI-04 PET/CT and PET/MR imaging in the diagnosis and staging of gastric cancer
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2028
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Gastric cancer
Who may be able to join
- Age over 18 years old;
- Diagnosed as a patient with gastric cancer;
- Receive FAPI PET/CT and FDG PET/CT imaging within one week;
- Perform serum tumor marker testing one week before and after scanning
Who cannot join
- History of other malignant tumors;
- Patients with severe infections, severe underlying diseases such as heart, kidney, and liver;
- Patients with contraindications for PET-CT examination, poor physical condition, and inability to tolerate the examination;
- Patients with unorganized pathology or incomplete clinical data
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, 1 recruiting
- Recruiting
Hunan Cancer hospital
Changsha, Hunan, 410000
Hui Ye, 86-13755117105, yuxin75831@163.com
About this study
This project aims to comprehensively analyze the diagnostic efficacy of SUVmax, SUVean, TLG, MTV, etc. in gastric cancer through 18F-FAPI-04 PET/CT imaging combined with serum tumor markers and other methods, and construct a molecular imaging diagnostic model for gastric cancer; Next, analyze the diagnostic efficacy of 18F-FAPI-04 PET/CT and PET/MR multimodal imaging in evaluating SUVmax, PET/CT-PCI, and PET/MR-PCI for gastric cancer peritoneal metastasis, and construct a molecular imaging diagnostic model for gastric cancer peritoneal metastasis; Exploring the clinical value of 18F-FAPI-04 PET/CT and PET/MR imaging in the diagnosis and staging of gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- The clinical value of 18F-FAPI-04 PET/CT and PET/MR imaging in the diagnosis and staging of gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The clinical value of 18F-FAPI-04 PET/CT and PET/MR imaging in the diagnosis and staging of gastric cancerDiagnostic test
The clinical value of 18F-FAPI-04 PET/CT and PET/MR imaging in the diagnosis and staging of gastric cancer
What is being measured
The primary outcome is the main question the study is designed to answer.
18F-FAPI-04 PET imaging diagnosis of gastric cancer detection rate
Exploring the feasibility of using targeted fibroblast activation protein (FAP) PET/CT imaging for gastric cancer; Compare the advantages and disadvantages of 18F-FAPI-04 and 18F-FDG in gastric cancer imaging, explore the clinical application value of 18F-FAPI-04 PET/CT in gastric cancer imaging, and construct a molecular imaging diagnostic model for gastric cancer
Measured: 2 years
Secondary outcomes (1)
Detection rate of peritoneal metastasis in gastric cancer
Comparison of the diagnostic value of 18F-FAPI-04 PET/CT and PET/MR for peritoneal metastasis of gastric cancer, and construction of a molecular imaging diagnostic model for peritoneal metastasis of gastric cancer
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (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 Gastric CancerStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui Ye, Hunan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543108
- Sponsor's protocol ID
- FAPI-001
- Status last verified
- Mar 2024
- First submitted
- 3 Aug 2024
- Last updated
- 7 Aug 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 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study on the Diagnostic Value Comparison of 18F-FAPI-04 PET/CT and PET/MR in Gastric Cancer
- ClinicalTrials.gov ID
- NCT06543108
- Acronym / sponsor ID
- FAPI-001
- Conditions
- Gastric Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Aug 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.
This project aims to comprehensively analyze the diagnostic efficacy of SUVmax, SUVean, TLG, MTV, etc. in gastric cancer through 18F-FAPI-04 PET/CT imaging combined with serum tumor markers and other methods, and construct a molecular imaging diagnostic model for gastric cancer; Next, analyze the diagnostic efficacy of 18F-FAPI-04 PET/CT and PET/MR multimodal imaging in evaluating SUVmax, PET/CT-PCI, and PET/MR-PCI for gastric cancer peritoneal metastasis, and construct a molecular imaging diagnostic model for gastric cancer peritoneal metastasis; Exploring the clinical value of 18F-FAPI-04 PET/CT and PET/MR imaging in the diagnosis and staging of gastric cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gastric cancer
Key inclusion criteria (4 listed)
- Age over 18 years old;
- Diagnosed as a patient with gastric cancer;
- Receive FAPI PET/CT and FDG PET/CT imaging within one week;
- Perform serum tumor marker testing one week before and after scanning
Key exclusion criteria (4 listed)
- History of other malignant tumors;
- Patients with severe infections, severe underlying diseases such as heart, kidney, and liver;
- Patients with contraindications for PET-CT examination, poor physical condition, and inability to tolerate the examination;
- Patients with unorganized pathology or incomplete clinical data
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 |
|---|---|---|
| The clinical value of 18F-FAPI-04 PET/CT and PET/MR imaging in the diagnosis and staging of gastric cancerThe clinical value of 18F-FAPI-04 PET/CT and PET/MR imaging in the diagnosis and staging of gastric cancer | Diagnostic test | – |
Primary outcome
18F-FAPI-04 PET imaging diagnosis of gastric cancer detection rate
Time frame: 2 years
Exploring the feasibility of using targeted fibroblast activation protein (FAP) PET/CT imaging for gastric cancer; Compare the advantages and disadvantages of 18F-FAPI-04 and 18F-FDG in gastric cancer imaging, explore the clinical application value of 18F-FAPI-04 PET/CT in gastric cancer imaging, and construct a molecular imaging diagnostic model for gastric cancer
1 secondary outcome
Detection rate of peritoneal metastasis in gastric cancer
Time frame: 2 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 7 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Gastric Cancer
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
Active, not recruitingPhase 2
A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors
Part 1: Bladder, Biliary Tract, Cervical, Endometrial, Ovarian, Pancreatic Cancer, Rare Tumors, Any Tumor Type Excluding Breast, Gastric, Colorectal Cancer, Part 2: HER2 Expressing/Amplified Solid Tumors Excluding Breast, Gastric, Colorectal Cancer
RecruitingPhase 1/2
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Gastric/GEJ
RecruitingPhase 4
Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)
Gastrointestinal Cancer, Gastric Cancer
RecruitingObservational study
Development and Utilization of an Integrated Clinical Genomic Database
Gastric Cancer, Colorectal Cancer
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 Gastric Cancer, run by Hunan Cancer 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 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: looking for participants now, as of the sponsor's last update on 7 Aug 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?
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 Hui Ye (86-13755117105, yuxin75831@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18F-FAPI-04 PET imaging diagnosis of gastric cancer detection rate (time frame: 2 years). 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 7 Aug 2024.