CancerNCT06327386
The Therapeutic Efficacy of 18F-FDG Combined With 18F-FAPI PET/MR in Neoadjuvant Therapy for Gastric Cancer
An observational study of Cancer, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
Gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer-related deaths. Although surgical treatment can benefit the survival of the vast majority of patients, currently only early gastric cancer patients can be cured directly through endoscopic resection or surgery alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- 18F-FAPI#18F-FDG
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Jan 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects the investigators selected are adults who are not restricted by gender.
Who may be able to join
- Diagnosed primary gastric adenocarcinoma patients (cT2N+non-surgical treatment, cT3NanyMany and above staging)
- Staging of MRI enhanced examination before neoadjuvant therapy
- Restaging of preoperative 18F-FAPI and 18F-FDG PET/MRI examination
- Postoperative resection was performed after neoadjuvant therapy, with postoperative pathology, regression grading, and related immunohistochemistry
- Patient age ≥ 18 years old
- The patient voluntarily participates and signs an informed consent form.
Who cannot join
- Severe comorbidities may interfere with treatment or affect disease-specific health-related quality of life
- Drug requirements that interfere with the research protocol
- Pregnant or lactating male subjects who are expected to conceive or cause their spouse to conceive during the planned trial period
- The imaging quality is poor and cannot be used for diagnosis and evaluation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Nuclear Medicine, Daping Hospital of Army Medical University
Chongqing, Chongqing Municipality, 400010
Xiao Chen, Ph.D, 15922970174, xiaochen229@foxmail.com
About this study
Gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer-related deaths. Although surgical treatment can benefit the survival of the vast majority of patients, currently only early gastric cancer patients can be cured directly through endoscopic resection or surgery alone. Neoadjuvant therapy reduces tumor volume and improves tumor response rate through preoperative radiotherapy and chemotherapy, thereby increasing R0 resection rate and improving overall survival, without increasing postoperative complications and mortality. Timely imaging re staging during neoadjuvant therapy can allow patients to enter the surgical stage earlier, thereby reducing their preoperative burden. According to the different stages of neoadjuvant therapy, clinical staging can be divided into baseline stage (cBSstage) and clinical rest stage (cReStage) after neoadjuvant therapy.
At present, the conventional imaging methods for diagnosing cBStage in gastric cancer include CT, endoscopic ultrasonography (EUS), and MRI. The NCCN guidelines recommend CT for cBStage, with a diagnostic accuracy of 77.1% to 88.9%. Similarly, EUS and MRI were also used for cBStage, with accuracy rates of 65.0% to 92.1% and 71.4% to 82.6%, respectively. The application of diffusion-weighted imaging (DWI) has improved the accuracy of MRI diagnosis of cBStage to 93%.
Read more
However, due to the destruction of the gastric wall structure by neoadjuvant therapy, accurate imaging re staging is difficult. Currently, accurate tumor regression grading can only be obtained through surgical resection of pathological specimens. For cReT after neoadjuvant therapy, the diagnostic accuracy of EUS is only 63% (T2: 44%, T3: 68%, T4: 90%). Due to the presence of chronic inflammatory reactions, such as tumor cell apoptosis, necrosis, fibrosis, etc., in both the tumor and the critical normal gastric wall after neoadjuvant therapy, imaging cannot accurately identify the level of gastric wall, leading to the current low value of CT for cReT. Meanwhile, due to the fact that the pathological reactions of lymph nodes after neoadjuvant therapy are mainly subacute inflammatory reactions accompanied by scar tissue formation, and not all lymph node volumes that experience these pathological reactions will rapidly decrease, the accuracy of CT diagnosis of cReN is only 44%, while the sensitivity and specificity of EUS diagnosis of cReN are 50% and 56%, respectively.
In addition, positron emission tomography (PET) can reflect the abnormal metabolism, protein synthesis, DNA repair, and cell proliferation of tumors at the molecular level, providing important information in tumor grading diagnosis, prognosis evaluation, treatment decision-making, and efficacy monitoring. The conventional positron tracer 18F-FDG can reflect the glucose metabolism ability of different tissues, while most types of malignant tumors exhibit high metabolism. Therefore, 18F-FDG can be used for the diagnosis, staging, and treatment monitoring of cancer. However, in gastric cancer patients, 18F-FDG has certain limitations, including 1) interference with physiological or inflammatory uptake of the gastric wall; 2) Low uptake of 18F-FDG is present in signet ring cell carcinoma, mucinous adenocarcinoma, or other poorly differentiated cancers with high mucus content; 3) There are cases of false positive FDG after immunotherapy. In the study of SUV changes in the tumor area before and after treatment, it was found that patients with postoperative pathological regression grades 1-5 Δ SUVs are between 0-70%.
Tumor associated fibroblasts are closely related to tumor growth, invasion, and distant metastasis, and their activation requires the involvement of fibroblast activation protein (FAP). Therefore, radiolabeled fibroblast activation protein inhibitor (FAPI) can achieve in vivo FAP targeted tracing and quantification by specifically binding to FAP. Currently, a large number of studies have shown that 18F-FAPI is superior to 18F-FDG in the staging and re staging of gastric cancer. Furthermore, prospective studies have shown a certain relationship between tumor regression grade (TRG) and 18F-FAPI rate of change parameters (SUVmax, SUVavg, SUVR).
Therefore, in the early stage of this study, 18F-FAPI combined with 18F-FDG PET/MRI imaging was used to evaluate the efficacy of neoadjuvant therapy for gastric cancer, preoperative assessment of tumor regression grade after treatment, and re staging to guide the development of further clinical treatment plans.
Read the detailed description
This study is a prospective, single study and has been approved by the ethics committee. The subjects of this studywere from January 1,2024 to January 1,2026.The detailed description is as follows:
- Patients: A patient with primary gastric adenocarcinoma who underwent surgical resection after neoadjuvant treatment at the Army Specialized Medical Center from January 2024 to January 2026.
- Clinical data colection: Record the course of disease, laboratory tests (tumor markers), pre neoadjuvant MRI enhancement, PET/MR examination, postoperative pathology, and related immunohistochemistry of all patients.
- PETMR image analysis: Record and evaluate the following indicators:the maximum, mean standardized uptakevalue (SUVmax, SUVmean) and standard uptake value ratio.
- Pathological analysis: After collecting pathological specimens of the primary lesion and metastatic lymph nodes after surgery, they were fixed with formalin solution and embedded in paraffin, and three slices with a thickness of 4 were taken μ Slice of m. The first slice was stained with HE; The second slice was stained for glucose transporter 1 (GLUT1); The third slice was stained with Fibroblast Activation Protein (FAP). And record the primary lesion regression grade (TRG).
- Statiscal analysis: Statistical analysis: Use descriptive statistical methods to compare the age of patients and the standardized uptake values of FDG and FAPI. Normal distribution data is represented as mean ± standard deviation, while non normal distribution data is represented as median with IQR. Compare the normal distribution data between two groups using paired two sample t-test, and compare the non normal distribution data between two groups using McNemar test. Using a four grid table McNemar χ Compare the diagnostic efficacy of 18F-FDG PET and 18F-FAPI PET through 2 tests, calculate and compare the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 18F-FDG and 18F-FAPI PET. Due to the potential impact of tumor type on diagnosis, subgroup analysis was conducted on the diagnostic efficacy of 18F-FDG PET and 18F-FAPI PET. Due to the possibility of multiple metastatic lesions in a given participant, the diagnostic results may be correlated within the participant. Therefore, sensitivity analysis of metastatic lesions is also performed based on a generalized linear mixed effects model by combining this correlation between different lesions within the same participant. Double tailed P<0.05 indicates a statistically significant difference.
- Conditions
- Cancer
- Being tested
- 18F-FAPI#18F-FDG
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FAPI#18F-FDGDiagnostic test
FAPI and FDG combined with PET/MR imaging in patients with gastric cancer after neoadjuvant therapy
| Study group | Role | What they receive |
|---|---|---|
| After neoadjuvant therapy for gastric cancer | * Diagnosed primary gastric adenocarcinoma patients (cT2N+non-surgical treatment, cT3NanyMany and above staging)
* Staging of MRI enhanced examination before neoadjuvant therapy
* Restaging of preoperative 18F-FAPI and 18F-FDG PET/MRI examination
* Postoperative resection was performed after neoadjuvant therapy, with postoperative pathology, regression grading, and related immunohistochemistry
* Patient age ≥ 18 years old
* The patient voluntarily participates and signs an informed consent form. Receives: Diagnostic Test: 18F-FAPI#18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation efficacy of tumor regression level
The sensitivity, specificity, positive predictive value (PPV), negative predictive value
Measured: Completed within half year after end of the study
Secondary outcomes (3)
expression of FAP
Immunohistochemical evaluation of the expression of FAP in postoperative tumor tissue
Measured: completed within one week after surgery
expression of GLUT1
Immunohistochemical evaluation of the expression of CLUT1 in postoperative tumor tissue
Measured: completed within one week after surgery
SUV
Standardized uptake value (SUV) of 18F-FDG and 18F-FAPI for each target lesion of subject or suspected primary tumor or/and metastasis.
Measured: Completed within one week after PET examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
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 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao Chen, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327386
- Sponsor's protocol ID
- 202434
- Status last verified
- Aug 2024
- First submitted
- 17 Mar 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yoshikawa T, Tanabe K, Nishikawa K, Ito Y, Matsui T, Kimura Y, Hasegawa S, Aoyama T, Hayashi T, Morita S, Miyashita Y, Tsuburaya A, Sakamoto J. Accuracy of CT staging of locally advanced gastric cancer after neoadjuvant chemotherapy: cohort evaluation within a randomized phase II study. Ann Surg Oncol. 2014 Jun;21 Suppl 3:S385-9. doi: 10.1245/s10434-014-3615-8. Epub 2014 Mar 5.
PubMed 24595801
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Therapeutic Efficacy of 18F-FDG Combined With 18F-FAPI PET/MR in Neoadjuvant Therapy for Gastric Cancer
- ClinicalTrials.gov ID
- NCT06327386
- Acronym / sponsor ID
- 202434
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 25 Mar 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.
Gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer-related deaths. Although surgical treatment can benefit the survival of the vast majority of patients, currently only early gastric cancer patients can be cured directly through endoscopic resection or surgery alone. Neoadjuvant therapy reduces tumor volume and improves tumor response rate through preoperative radiotherapy and chemotherapy, thereby increasing R0 resection rate and improving overall survival, without increasing postoperative complications and mortality. Timely imaging re staging during neoadjuvant therapy can allow patients to enter the surgical stage earlier, thereby reducing their preoperative burden. According to the different stages of neoadjuvant therapy, clinical staging can be divided into baseline stage (cBSstage) and clinical rest stage (cReStage) after neoadjuvant therapy.
At present, the conventional imaging methods for diagnosing cBStage in gastric cancer include CT, endoscopic ultrasonography (EUS), and MRI. The NCCN guidelines recommend CT for cBStage, with a diagnostic accuracy of 77.1% to 88.9%. Similarly, EUS and MRI were also used for cBStage, with accuracy rates of 65.0% to 92.1% and 71.4% to 82.6%, respectively. The application of diffusion-weighted imaging (DWI) has improved the accuracy of MRI diagnosis of cBStage to 93%.
However, due to the destruction of the gastric wall structure by neoadjuvant therapy, accurate imaging re staging is difficult. Currently, accurate tumor regression grading can only be obtained through surgical resection of pathological specimens. For cReT after neoadjuvant therapy, the diagnostic accuracy of EUS is only 63% (T2: 44%, T3: 68%, T4: 90%). Due to the presence of chronic inflammatory reactions, such as tumor cell apoptosis, necrosis, fibrosis, etc., in both the tumor and the critical normal gastric wall after neoadjuvant therapy, imaging cannot accurately identify the level of gastric wall, leading to the current low value of CT for cReT. Meanwhile, due to the fact that the pathological reactions of lymph nodes after neoadjuvant therapy are mainly subacute inflammatory reactions accompanied by scar tissue formation, and not all lymph node volumes that experience these pathological reactions will rapidly decrease, the accuracy of CT diagnosis of cReN is only 44%, while the sensitivity and specificity of EUS diagnosis of cReN are 50% and 56%, respectively.
In addition, positron emission tomography (PET) can reflect the abnormal metabolism, protein synthesis, DNA repair, and cell proliferation of tumors at the molecular level, providing important information in tumor grading diagnosis, prognosis evaluation, treatment decision-making, and efficacy monitoring. The conventional positron tracer 18F-FDG can reflect the glucose metabolism ability of different tissues, while most types of malignant tumors exhibit high metabolism. Therefore, 18F-FDG can be used for the diagnosis, staging, and treatment monitoring of cancer. However, in gastric cancer patients, 18F-FDG has certain limitations, including 1) interference with physiological or inflammatory uptake of the gastric wall; 2) Low uptake of 18F-FDG is present in signet ring cell carcinoma, mucinous adenocarcinoma, or other poorly differentiated cancers with high mucus content; 3) There are cases of false positive FDG after immunotherapy. In the study of SUV changes in the tumor area before and after treatment, it was found that patients with postoperative pathological regression grades 1-5 Δ SUVs are between 0-70%.
Tumor associated fibroblasts are closely related to tumor growth, invasion, and distant metastasis, and their activation requires the involvement of fibroblast activation protein (FAP). Therefore, radiolabeled fibroblast activation protein inhibitor (FAPI) can achieve in vivo FAP targeted tracing and quantification by specifically binding to FAP. Currently, a large number of studies have shown that 18F-FAPI is superior to 18F-FDG in the staging and re staging of gastric cancer. Furthermore, prospective studies have shown a certain relationship between tumor regression grade (TRG) and 18F-FAPI rate of change parameters (SUVmax, SUVavg, SUVR).
Therefore, in the early stage of this study, 18F-FAPI combined with 18F-FDG PET/MRI imaging was used to evaluate the efficacy of neoadjuvant therapy for gastric cancer, preoperative assessment of tumor regression grade after treatment, and re staging to guide the development of further clinical treatment plans.
Detailed description
This study is a prospective, single study and has been approved by the ethics committee. The subjects of this studywere from January 1,2024 to January 1,2026.The detailed description is as follows:
- Patients: A patient with primary gastric adenocarcinoma who underwent surgical resection after neoadjuvant treatment at the Army Specialized Medical Center from January 2024 to January 2026.
- Clinical data colection: Record the course of disease, laboratory tests (tumor markers), pre neoadjuvant MRI enhancement, PET/MR examination, postoperative pathology, and related immunohistochemistry of all patients.
- PETMR image analysis: Record and evaluate the following indicators:the maximum, mean standardized uptakevalue (SUVmax, SUVmean) and standard uptake value ratio.
- Pathological analysis: After collecting pathological specimens of the primary lesion and metastatic lymph nodes after surgery, they were fixed with formalin solution and embedded in paraffin, and three slices with a thickness of 4 were taken μ Slice of m. The first slice was stained with HE; The second slice was stained for glucose transporter 1 (GLUT1); The third slice was stained with Fibroblast Activation Protein (FAP). And record the primary lesion regression grade (TRG).
- Statiscal analysis: Statistical analysis: Use descriptive statistical methods to compare the age of patients and the standardized uptake values of FDG and FAPI. Normal distribution data is represented as mean ± standard deviation, while non normal distribution data is represented as median with IQR. Compare the normal distribution data between two groups using paired two sample t-test, and compare the non normal distribution data between two groups using McNemar test. Using a four grid table McNemar χ Compare the diagnostic efficacy of 18F-FDG PET and 18F-FAPI PET through 2 tests, calculate and compare the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 18F-FDG and 18F-FAPI PET. Due to the potential impact of tumor type on diagnosis, subgroup analysis was conducted on the diagnostic efficacy of 18F-FDG PET and 18F-FAPI PET. Due to the possibility of multiple metastatic lesions in a given participant, the diagnostic results may be correlated within the participant. Therefore, sensitivity analysis of metastatic lesions is also performed based on a generalized linear mixed effects model by combining this correlation between different lesions within the same participant. Double tailed P<0.05 indicates a statistically significant difference.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| After neoadjuvant therapy for gastric cancer | – | Diagnostic Test: 18F-FAPI#18F-FDG* Diagnosed primary gastric adenocarcinoma patients (cT2N+non-surgical treatment, cT3NanyMany and above staging) * Staging of MRI enhanced examination before neoadjuvant therapy * Restaging of preoperative 18F-FAPI and 18F-FDG PET/MRI examination * Postoperative resection was performed after neoadjuvant therapy, with postoperative pathology, regression grading, and related immunohistochemistry * Patient age ≥ 18 years old * The patient voluntarily participates and signs an informed consent form. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects the investigators selected are adults who are not restricted by gender.
Key inclusion criteria (6 listed)
- Diagnosed primary gastric adenocarcinoma patients (cT2N+non-surgical treatment, cT3NanyMany and above staging)
- Staging of MRI enhanced examination before neoadjuvant therapy
- Restaging of preoperative 18F-FAPI and 18F-FDG PET/MRI examination
- Postoperative resection was performed after neoadjuvant therapy, with postoperative pathology, regression grading, and related immunohistochemistry
- Patient age ≥ 18 years old
Key exclusion criteria (4 listed)
- Severe comorbidities may interfere with treatment or affect disease-specific health-related quality of life
- Drug requirements that interfere with the research protocol
- Pregnant or lactating male subjects who are expected to conceive or cause their spouse to conceive during the planned trial period
- The imaging quality is poor and cannot be used for diagnosis and evaluation.
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#18F-FDGFAPI and FDG combined with PET/MR imaging in patients with gastric cancer after neoadjuvant therapy | Diagnostic test | After neoadjuvant therapy for gastric cancer |
Primary outcome
Evaluation efficacy of tumor regression level
Time frame: Completed within half year after end of the study
The sensitivity, specificity, positive predictive value (PPV), negative predictive value
3 secondary outcomes
expression of FAP
Time frame: completed within one week after surgery
expression of GLUT1
Time frame: completed within one week after surgery
SUV
Time frame: Completed within one week after PET examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Results publication: PubMed 24595801Yoshikawa T, Tanabe K, Nishikawa K, Ito Y, Matsui T, Kimura Y, Hasegawa S, Aoyama T, Hayashi T, Morita S, Miyashita Y, Tsuburaya A, Sakamoto J. Accuracy of CT staging of locally advanced gastric cancer after neoadjuvant chemotherapy: cohort evaluation within a randomized phase II study. Ann Surg Oncol. 2014 Jun;21 Suppl 3:S385-9. doi: 10.1245/s10434-014-3615-8. Epub 2014 Mar 5.
- 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.
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, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical 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 6 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: status not confirmed, as of the sponsor's last update on 14 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiao Chen, Ph.D (+8615922970174, xiaochen229@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation efficacy of tumor regression level (time frame: Completed within half year after end of the study). 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 NCT06327386, 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 14 Aug 2024.