Peritoneal MetastasisNCT06597526
The Role of 18F-FDG&68Ga-FAPI PET/CT in the Assessment of Conversion Therapy Efficacy in Gastric Cancer with Peritoneal Metastasis.
An observational study of Peritoneal Metastasis and Gastric Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
This study aims to investigate the value of 18F-FDG\&68Ga-FAPI PET/CT in evaluating the outcome of conversion therapy and the prognosis of people with peritoneal metastases from gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Metastasis, Gastric Cancer
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2024to 31 May 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible inpatients and outpatients from Ruijin Hospital
Who may be able to join
- Histologically confirmed gastric adenocarcinoma with no history of resection of primary or metastatic lesions
- Peritoneal metastases of gastric cancer requiring laparoscopy for definitive diagnosis without gastric outflow tract obstruction and intestinal obstruction
- Patients voluntarily enrolled in this study by signing an informed consent form
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) score ≤ 2,
- Expected life expectancy ≥ 3 months
- Adequate organ and bone marrow function
- Willingness to adhere to the study protocol and follow-up programme
Who cannot join
- Signs of distant metastases other than peritoneal metastases at enrolment
- Pregnant or breastfeeding women.
- Patients with a history of other malignant diseases in the last 5 years, except cured skin cancer and carcinoma in situ of cervix
- Severe mental disease, uncontrolled epilepsy, or central nervous system disease
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
Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
Shanghai, Shanghai Municipality, 200025
Zhongyin Yang, 0086-13564877661, zyyang@shsmu.edu.cn
About this study
Official title: The Role of 18F-FDG & 68Ga-FAPI PET/CT in the Assessment of Conversion Therapy Efficacy in Gastric Cancer with Peritoneal Metastatic
This study aims to investigate the value of 18F-FDG\&68Ga-FAPI PET/CT in evaluating the outcome of conversion therapy and the prognosis of people with peritoneal metastases from gastric cancer.
Read the detailed description
If the target population of the study agrees to participate in the study, we will number the participants, resume their pathology files, and collect their gender, age, phone number, height and weight information, record the participants\' consultation process and the results of the tests and examinations therein. During the course of the study we will perform 18F-FDG \& 68Ga-FAPI PET/CT according to the participant\'s stage of disease, specifically: one 18F-FDG PET/CT prior to conversion therapy and one 68Ga-FAPI PET/CT as a baseline assessment. One 18F-FDG PET/CT and one 68Ga-FAPI PET/CT were performed before the clinician assessed that the conversion therapy was ready to be completed and the conversion surgery was about to be performed, and if the participant experienced a postoperative recurrence of the disease during the study period, another 18F-FDG PET/CT and a 68Ga-FAPI PET/CT would be performed, meaning that a total of 4 PET/CTs were performed. In other words, a total of 4 PET/CT visualizations were required for all participants; 2 additional PET/CT visualizations, including 18F-FDG PET/CT and 68Ga-FAPI PET/CT, were performed if the disease recurred after the conversion surgery, and none were required for participants without recurrence.
- Conditions
- Peritoneal Metastasis, Gastric Cancer
- Keywords
- 18F-FDG PET/CT, 68Ga-FAPI PET/CT, gastric cancer, peritoneal metastases, conversion therapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| gastric cancer patients with peritoneal metastasis | Initial diagnosis of gastric cancer with peritoneal metastases, excluding other distant metastases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target-to-background ratio(TBR)
68Ga-FAPI and 18F-FDG uptake ratio of primary gastric lesions, peritoneal lesions and recurrent metastatic lesions to mediastinum and liver blood pool on PET/CT images.
Measured: Baseline, preoperative assessment and time of postoperative recurrence assessment
Standardized uptake value(SUV)
SUV of 68Ga-FAPI and 18F-FDG uptake on PET/CT images for primary gastric lesions, peritoneal lesions and recurrent metastatic lesions
Measured: Baseline, preoperative assessment and time of postoperative recurrence assessment
Evaluation the outcome of conversion therapy
The value of 68Ga-FAPI PET/CT and 18F-FDG PET/CT in evaluating the outcome of conversion therapy in gastric cancer with peritoneal metastasis.
Measured: Baseline and preoperative assessment
Secondary outcomes (2)
Progress free survival
Progress free survival
Measured: 3 years
Overall survival
Overall survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Jun 2024
- Primary completion31 Mar 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal MetastasisStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Jiajia, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597526
- Sponsor's protocol ID
- RuijinH 2024-93
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of 18F-FDG & 68Ga-FAPI PET/CT in the Assessment of Conversion Therapy Efficacy in Gastric Cancer with Peritoneal Metastatic
- ClinicalTrials.gov ID
- NCT06597526
- Acronym / sponsor ID
- RuijinH 2024-93
- Conditions
- Peritoneal Metastasis, Gastric Cancer
- Keywords
- 18F-FDG PET/CT, 68Ga-FAPI PET/CT, gastric cancer, peritoneal metastases, conversion therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 15 Jun 2024 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 19 Sep 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 study aims to investigate the value of 18F-FDG\&68Ga-FAPI PET/CT in evaluating the outcome of conversion therapy and the prognosis of people with peritoneal metastases from gastric cancer.
Detailed description
If the target population of the study agrees to participate in the study, we will number the participants, resume their pathology files, and collect their gender, age, phone number, height and weight information, record the participants\' consultation process and the results of the tests and examinations therein. During the course of the study we will perform 18F-FDG \& 68Ga-FAPI PET/CT according to the participant\'s stage of disease, specifically: one 18F-FDG PET/CT prior to conversion therapy and one 68Ga-FAPI PET/CT as a baseline assessment. One 18F-FDG PET/CT and one 68Ga-FAPI PET/CT were performed before the clinician assessed that the conversion therapy was ready to be completed and the conversion surgery was about to be performed, and if the participant experienced a postoperative recurrence of the disease during the study period, another 18F-FDG PET/CT and a 68Ga-FAPI PET/CT would be performed, meaning that a total of 4 PET/CTs were performed. In other words, a total of 4 PET/CT visualizations were required for all participants; 2 additional PET/CT visualizations, including 18F-FDG PET/CT and 68Ga-FAPI PET/CT, were performed if the disease recurred after the conversion surgery, and none were required for participants without recurrence.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gastric cancer patients with peritoneal metastasis | – | –Initial diagnosis of gastric cancer with peritoneal metastases, excluding other distant metastases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible inpatients and outpatients from Ruijin Hospital
Key inclusion criteria (8 listed)
- Histologically confirmed gastric adenocarcinoma with no history of resection of primary or metastatic lesions
- Peritoneal metastases of gastric cancer requiring laparoscopy for definitive diagnosis without gastric outflow tract obstruction and intestinal obstruction
- Patients voluntarily enrolled in this study by signing an informed consent form
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) score ≤ 2,
Key exclusion criteria (4 listed)
- Signs of distant metastases other than peritoneal metastases at enrolment
- Pregnant or breastfeeding women.
- Patients with a history of other malignant diseases in the last 5 years, except cured skin cancer and carcinoma in situ of cervix
- Severe mental disease, uncontrolled epilepsy, or central nervous system disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Target-to-background ratio(TBR)
Time frame: Baseline, preoperative assessment and time of postoperative recurrence assessment
68Ga-FAPI and 18F-FDG uptake ratio of primary gastric lesions, peritoneal lesions and recurrent metastatic lesions to mediastinum and liver blood pool on PET/CT images.
Standardized uptake value(SUV)
Time frame: Baseline, preoperative assessment and time of postoperative recurrence assessment
SUV of 68Ga-FAPI and 18F-FDG uptake on PET/CT images for primary gastric lesions, peritoneal lesions and recurrent metastatic lesions
Evaluation the outcome of conversion therapy
Time frame: Baseline and preoperative assessment
The value of 68Ga-FAPI PET/CT and 18F-FDG PET/CT in evaluating the outcome of conversion therapy in gastric cancer with peritoneal metastasis.
2 secondary outcomes
Progress free survival
Time frame: 3 years
Overall survival
Time frame: 3 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 19 Sep 2024.
- 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.
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 Peritoneal Metastasis and Gastric Cancer, run by Ruijin 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 8 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 19 Sep 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 Jiajia Hu (0086-13524945287, jiajiahu@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target-to-background ratio(TBR) (time frame: Baseline, preoperative assessment and time of postoperative recurrence assessment). The study lists 3 primary outcomes in all. 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 19 Sep 2024.