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

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ClinicalTrials.gov Identifier: NCT04778345
Recruitment Status : Not yet recruiting
First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Chang-Ming Huang, Prof., Fujian Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Enhanced CT 18F-FDG PET/CT 68Ga-FAPI PET/CT Gastric Cancer Peritoneal Carcinomatosis Diagnostic Test: 68Ga-FAPI PET/CT scan Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04778345


Contacts
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Contact: Chang-Ming Huang, MD +86-13805069676 hcmlr2002@163.com
Contact: Zu-Kai Wang, MD +86-15659036263 413966027@qq.com

Locations
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China, Fujian
Department of Gastric Surgery
Fuzhou, Fujian, China
Sponsors and Collaborators
Fujian Medical University
Investigators
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Study Chair: Chang-Ming Huang, MD Fujian Medical University Union Hospital
More Information
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Publications:

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Responsible Party: Chang-Ming Huang, Prof., Professor, Fujian Medical University
ClinicalTrials.gov Identifier: NCT04778345    
Other Study ID Numbers: FUGES-021
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: March 3, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stomach Neoplasms
Carcinoma
Peritoneal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abdominal Neoplasms
Peritoneal Diseases