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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04778345
• Other study ID #: FUGES-021
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2021
• Est. completion date: March 2023

Study information

• Verified date: February 2021
• Source: Fujian Medical University
• Contact: Chang-Ming Huang, MD
• Phone: +86-13805069676
• Email: hcmlr2002[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: March 2023
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• 18F-FDG PET/CT
• 68Ga-FAPI PET/CT
• Carcinoma
• Enhanced CT
• Gastric Cancer
• Peritoneal Carcinomatosis
• Peritoneal Neoplasms
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Department of Gastric Surgery	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

References & Publications (14)

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Chen H, Pang Y, Wu J, Zhao L, Hao B, Wu J, Wei J, Wu S, Zhao L, Luo Z, Lin X, Xie C, Sun L, Lin Q, Wu H. Comparison of [(68)Ga]Ga-DOTA-FAPI-04 and [(18)F] FDG PET/CT for the diagnosis of primary and metastatic lesions in patients with various types of cancer. Eur J Nucl Med Mol Imaging. 2020 Jul;47(8):1820-1832. doi: 10.1007/s00259-020-04769-z. Epub 2020 Mar 28. — View Citation

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Kim JH, Jang YJ, Park SS, Park SH, Kim SJ, Mok YJ, Kim CS. Surgical outcomes and prognostic factors for T4 gastric cancers. Asian J Surg. 2009 Oct;32(4):198-204. doi: 10.1016/S1015-9584(09)60395-X. — View Citation

Kratochwil C, Flechsig P, Lindner T, Abderrahim L, Altmann A, Mier W, Adeberg S, Rathke H, Röhrich M, Winter H, Plinkert PK, Marme F, Lang M, Kauczor HU, Jäger D, Debus J, Haberkorn U, Giesel FL. (68)Ga-FAPI PET/CT: Tracer Uptake in 28 Different Kinds of Cancer. J Nucl Med. 2019 Jun;60(6):801-805. doi: 10.2967/jnumed.119.227967. Epub 2019 Apr 6. — View Citation

Kurita N, Shimada M, Utsunomiya T, Iwata T, Nishioka M, Yoshikawa K, Miyatani T, Higashijima J, Nakao T. Predictive factors of peritoneal metastasis in gastric cancer. Hepatogastroenterology. 2010 Jul-Aug;57(101):980-3. — View Citation

Nakagawa S, Nashimoto A, Yabusaki H. Role of staging laparoscopy with peritoneal lavage cytology in the treatment of locally advanced gastric cancer. Gastric Cancer. 2007;10(1):29-34. Epub 2007 Feb 23. — View Citation

Pang Y, Zhao L, Luo Z, Hao B, Wu H, Lin Q, Sun L, Chen H. Comparison of (68)Ga-FAPI and (18)F-FDG Uptake in Gastric, Duodenal, and Colorectal Cancers. Radiology. 2021 Feb;298(2):393-402. doi: 10.1148/radiol.2020203275. Epub 2020 Dec 1. — View Citation

Rettig WJ, Su SL, Fortunato SR, Scanlan MJ, Raj BK, Garin-Chesa P, Healey JH, Old LJ. Fibroblast activation protein: purification, epitope mapping and induction by growth factors. Int J Cancer. 1994 Aug 1;58(3):385-92. — View Citation

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Smyth E, Schöder H, Strong VE, Capanu M, Kelsen DP, Coit DG, Shah MA. A prospective evaluation of the utility of 2-deoxy-2-[(18) F]fluoro-D-glucose positron emission tomography and computed tomography in staging locally advanced gastric cancer. Cancer. 2012 Nov 15;118(22):5481-8. doi: 10.1002/cncr.27550. Epub 2012 May 1. — View Citation

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* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic efficacy for peritoneal carcinomatosis	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
Primary	Maximum standardized uptake value [SUVmax (for PET/CT only)] for peritoneal carcinomatosis	SUVmax of 68Ga-FAPI PET/CT for peritoneal carcinomatosis in comparison with 18F-FDG PET/CT	One month after surgery
Secondary	Predictive value for peritoneal carcinomatosis by using radiomic algorithm	Prediction value of three kinds of imaging examination for peritoneal carcinomatosis by using radiomic algorithm	One month after surgery
Secondary	Diagnostic efficacy for primary lesions	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
Secondary	SUVmax (for PET/CT only) for primary lesions	SUVmax of 68Ga-FAPI PET/CT for primary lesions in comparison with 18F-FDG PET/CT	One month after surgery
Secondary	Diagnostic efficacy for metastatic lymph nodes	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
Secondary	SUVmax (for PET/CT only) for metastatic lymph nodes	SUVmax of 68Ga-FAPI PET/CT for metastatic lymph nodes in comparison with 18F-FDG PET/CT	One month after surgery
Secondary	Correlation between the expression of fibroblast activation protein (FAP) and 68Ga-FAPI uptake in different pathological types of peritoneal carcinomatosis	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
Secondary	Correlation between the expression of FAP and 68Ga-FAPI uptake in different pathological types of primary lesions	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
Secondary	Correlation between the expression of FAP and 68Ga-FAPI uptake in different pathological types of metastatic lymph nodes	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
Secondary	Predictive value of conversion therapy efficacy	Predictive value of three kinds of imaging examination for gastric cancer in conversion therapy response assessment	One month after surgery
Secondary	1-year progression-free survival rate	The relationship between three kinds of imaging examination and the patient's 1-year progression-free survival rate	12 months
Secondary	1-year progression patterns	The relationship between the three types of imaging examinations and the patient's 1-year progression patterns	12 months