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

February 26, 2021 updated by: Chang-Ming Huang, Prof., Fujian Medical University

Preoperative Abdominal Enhanced CT, 18F-FDG PET/CT and 68Ga-FAPI PET/CT to Detect Peritoneal Carcinomatosis in High-Risk Patients With Gastric Cancer: A Prospective, Single-Center, Comparative Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China
        • Department of Gastric Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic efficacy for peritoneal carcinomatosis
Time Frame: One month after surgery
Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) of 68Ga-FAPI PET/CT for peritoneal carcinomatosis in comparison with 18F-FDG PET/CT and abdominal enhanced CT
One month after surgery
Maximum standardized uptake value [SUVmax (for PET/CT only)] for peritoneal carcinomatosis
Time Frame: One month after surgery
SUVmax of 68Ga-FAPI PET/CT for peritoneal carcinomatosis in comparison with 18F-FDG PET/CT
One month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predictive value for peritoneal carcinomatosis by using radiomic algorithm
Time Frame: One month after surgery
Prediction value of three kinds of imaging examination for peritoneal carcinomatosis by using radiomic algorithm
One month after surgery
Diagnostic efficacy for primary lesions
Time Frame: One month after surgery
Sensitivity, specificity, accuracy, PPV and NPV of 68Ga-FAPI PET/CT for primary lesions in comparison with 18F-FDG PET/CT and abdominal enhanced CT
One month after surgery
SUVmax (for PET/CT only) for primary lesions
Time Frame: One month after surgery
SUVmax of 68Ga-FAPI PET/CT for primary lesions in comparison with 18F-FDG PET/CT
One month after surgery
Diagnostic efficacy for metastatic lymph nodes
Time Frame: One month after surgery
Sensitivity, specificity, accuracy, PPV and NPV of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with 18F-FDG PET/CT and abdominal enhanced CT
One month after surgery
SUVmax (for PET/CT only) for metastatic lymph nodes
Time Frame: One month after surgery
SUVmax of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with 18F-FDG PET/CT
One month after surgery
Correlation between the expression of fibroblast activation protein (FAP) and 68Ga-FAPI uptake in different pathological types of peritoneal carcinomatosis
Time Frame: One month after surgery
Analyzing the correlation between the SUVmax of 68Ga-FAPI in peritoneal carcinomatosis with different pathological types and FAP identified by pathological examinations
One month after surgery
Correlation between the expression of FAP and 68Ga-FAPI uptake in different pathological types of primary lesions
Time Frame: One month after surgery
Analyzing the correlation between the SUVmax of 68Ga-FAPI in primary lesions with different pathological types and FAP identified by pathological examinations
One month after surgery
Correlation between the expression of FAP and 68Ga-FAPI uptake in different pathological types of metastatic lymph nodes
Time Frame: One month after surgery
Analyzing the correlation between the SUVmax of 68Ga-FAPI in metastatic lymph nodes with different pathological types and FAP identified by pathological examinations
One month after surgery
Predictive value of conversion therapy efficacy
Time Frame: One month after surgery
Predictive value of three kinds of imaging examination for gastric cancer in conversion therapy response assessment
One month after surgery
1-year progression-free survival rate
Time Frame: 12 months
The relationship between three kinds of imaging examination and the patient's 1-year progression-free survival rate
12 months
1-year progression patterns
Time Frame: 12 months
The relationship between the three types of imaging examinations and the patient's 1-year progression patterns
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University

Investigators

  • Study Chair: Chang-Ming Huang, MD, Fujian Medical University Union Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

February 22, 2021

First Submitted That Met QC Criteria

February 26, 2021

First Posted (Actual)

March 3, 2021

Study Record Updates

Last Update Posted (Actual)

March 3, 2021

Last Update Submitted That Met QC Criteria

February 26, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUGES-021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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