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

NCT06597526 | Recruiting

• 1 other identifier: RuijinH 2024-93
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Metastasis; Gastric Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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.

  Baseline and preoperative assessment

Secondary Outcomes (2)

• Progress free survival

  3 years

• Overall survival

  3 years

Study Arms (1)

gastric cancer patients with peritoneal metastasis

Initial diagnosis of gastric cancer with peritoneal metastases, excluding other distant metastases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible inpatients and outpatients from Ruijin Hospital

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Jiajia Hu

CONTACT

0086-13524945287; jiajiahu@shsmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nuclear medicine

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: June 15, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): May 31, 2029
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)