Preoperative Abdominal Enhanced CT, 18F-FDG PET/CT and 68Ga-FAPI PET/CT in Peritoneal Carcinomatosis of Gastric Cancer

NCT ID: NCT04778345

Last Updated: 2021-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2023-03-31

Brief Summary

This study aims to explore the value of 68Ga-FAPI PET/CT in the diagnosis of gastric cancer peritoneal carcinomatosis in high-risk patients compared with conventional abdominal enhanced CT and 18F-FDG PET/CT. The patients with gastric adenocarcinoma (cT4/N+/M0-1) will be studied.

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will receive 68Ga-FAPI PET/CT on the 2nd day to 1st week of 18F-FDG PET/CT. On PET/CT, omentum, peritoneum, and mesenteric lesions with increased radioactive uptake are defined as suspicious peritoneal carcinomatosis. The number of these positive lesions, the maximum standardized uptake value (SUVmax), median and range will be recorded. Subsequently, the patients will undergo laparoscopic exploration, and if radical resection is assessed, radical gastrectomy (D2 lymph node dissection) will be performed. If a radical resection is not feasible, for patients with peritoneal carcinomatosis detected, one metastasis will be taken for rapid frozen diagnosis. After the peritoneal carcinomatosis is confirmed, the metastases seen under laparoscopy will be matched with the suspicious peritoneal carcinomatosis on the three preoperative imaging examinations. The intraoperative findings are used as the gold standard to compare the detection efficiency of the three imaging examinations for peritoneal carcinomatosis. Patients with unresected tumors will receive 4 cycles of conversion therapy or neoadjuvant therapy. After the treatment, 18F-FDG PET/CT and 68Ga-FAPI PET/CT will be performed again. If necessary, patients will be subjected to a second laparoscopic exploration, and radical gastrectomy (D2 lymph node dissection) will be performed for appropriate patients. If a radical resection is still not feasible, for patients with peritoneal carcinomatosis detected, biopsy of metastases will be performed if necessary.

Conditions

Enhanced CT; 18F-FDG PET/CT; 68Ga-FAPI PET/CT; Gastric Cancer; Peritoneal Carcinomatosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

18F-FDG PET/CT and 68Ga-FAPI PET/CT scan after abdominal enhanced CT

After the patient received abdominal enhanced CT, 18F-FDG PET/CT and 68Ga-FAPI PET/CT were further performed. The interval between 18F-FDG PET/CT and 68Ga-FAPI PET/CT was 2 days to 1 week.

Group Type: EXPERIMENTAL

68Ga-FAPI PET/CT scan

Intervention Type: DIAGNOSTIC_TEST

Each subject receives a single intravenous injection of 68Ga-FAPI, and undergo PET/CT imaging after 18F-FDG PET/CT scan during 2 days and 1 week.

Interventions

68Ga-FAPI PET/CT scan

Each subject receives a single intravenous injection of 68Ga-FAPI, and undergo PET/CT imaging after 18F-FDG PET/CT scan during 2 days and 1 week.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Age from 18 to 75 years

2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy

3. The clinical tumor stage before PET/CT scan was evaluated as cT4/N+/M0-1, according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition

4. Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)

5. American Society of Anesthesiology score (ASA) class I, II, or III

6. Written informed consent

Exclusion Criteria

1. Women during pregnancy or breast-feeding

2. Severe mental disorder

3. History of previous abdominal inflammatory diseases (such as peritonitis, pancreatitis, cholecystitis, inflammatory bowel disease)

4. History of unstable angina or myocardial infarction within past six months

5. History of cerebrovascular accident within past six months

6. History of continuous systematic administration of corticosteroids within one month

7. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer

8. Forced expiratory volume in 1 second (FEV1)<50% of predicted values

9. History of allergy to tracer agents of PET/CT

10. History of allergy to contrast agents of CT

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Medical University

OTHER

Sponsor Role: lead

Responsible Party

Chang-Ming Huang, Prof.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chang-Ming Huang, MD

Role: STUDY_CHAIR

Fujian Medical University Union Hospital

Locations

Department of Gastric Surgery

Fuzhou, Fujian, China

Countries

China

Central Contacts

Chang-Ming Huang, MD

Role: CONTACT

hcmlr2002@163.com

+86-13805069676

Zu-Kai Wang, MD

Role: CONTACT

413966027@qq.com

+86-15659036263

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Other Identifiers

FUGES-021

Identifier Type: -

Identifier Source: org_study_id