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The Role of 18F-FDG&68Ga-FAPI PET/CT in the Assessment of Conversion Therapy Efficacy in Gastric Cancer with Peritoneal Metastasis.

The Role of 18F-FDG & 68Ga-FAPI PET/CT in the Assessment of Conversion Therapy Efficacy in Gastric Cancer with Peritoneal Metastatic

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06597526
Enrollment
30
Registered
2024-09-19
Start date
2024-06-15
Completion date
2029-05-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Peritoneal Metastasis

Keywords

18F-FDG PET/CT, 68Ga-FAPI PET/CT, gastric cancer, peritoneal metastases, conversion therapy

Brief 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.

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.

Interventions

None listed

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Histologically confirmed gastric adenocarcinoma with no history of resection of primary or metastatic lesions 2. Peritoneal metastases of gastric cancer requiring laparoscopy for definitive diagnosis without gastric outflow tract obstruction and intestinal obstruction 3. Patients voluntarily enrolled in this study by signing an informed consent form 4. Age ≥ 18 years 5. Eastern Cooperative Oncology Group (ECOG) score ≤ 2, 6. Expected life expectancy ≥ 3 months 7. Adequate organ and bone marrow function 8. Willingness to adhere to the study protocol and follow-up programme

Exclusion criteria

1. Signs of distant metastases other than peritoneal metastases at enrolment 2. Pregnant or breastfeeding women. 3. Patients with a history of other malignant diseases in the last 5 years, except cured skin cancer and carcinoma in situ of cervix 4. Severe mental disease, uncontrolled epilepsy, or central nervous system disease

Design outcomes

Primary

MeasureTime frameDescription
Target-to-background ratio(TBR)Baseline, preoperative assessment and time of postoperative recurrence assessment68Ga-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)Baseline, preoperative assessment and time of postoperative recurrence assessmentSUV 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 therapyBaseline and preoperative assessmentThe value of 68Ga-FAPI PET/CT and 18F-FDG PET/CT in evaluating the outcome of conversion therapy in gastric cancer with peritoneal metastasis.

Secondary

MeasureTime frameDescription
Progress free survival3 yearsProgress free survival
Overall survival3 yearsOverall survival

Countries

China

Contacts

Primary ContactJiajia Hu
jiajiahu@shsmu.edu.cn0086-13524945287

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026