Prediction of Peritoneal Metastasis for Gastric Cancer Based on Radiomics

Gastric Cancer Clinical Trial

Official title:

Prediction of Peritoneal Metastasis for Gastric Cancer Based on Radiomics: a Multi-center Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05722275
• Other study ID #: CASMI003
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: February 2023
• Source: Chinese Academy of Sciences
• Contact: Di Dong, Ph.D
• Phone: +86 010-82618465
• Email: di.dong[@]ia.ac.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Peritoneal metastasis of gastric cancer is difficult to be detected in time, thus delaying treatment. Based on the conventional CT images of gastric cancer, this study plans to develop, improve and validate an intelligent analysis system based on radiomics. By extracting and combining the radiomics features related to peritoneal metastasis of gastric cancer, the intelligent analysis system could predict the risk of peritoneal metastasis, and provide personalized decision suggestions for the treatment of gastric cancer.

Description:

Peritoneal metastasis of gastric cancer is difficult to be detected in time, thus delaying treatment. Based on the conventional CT images of gastric cancer, this study plans to develop, improve and validate an intelligent analysis system based on radiomics. By extracting and combining the radiomics features related to peritoneal metastasis of gastric cancer, the intelligent analysis system could predict the risk of peritoneal metastasis, and provide personalized decision suggestions for the treatment of gastric cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• (1) diagnosed advanced gastric cancer (=cT3) by endoscopy-biopsy pathology, combined with CT and/or endoscopic ultrasound;
• (2) with both enhanced CT and laparoscopy;
• (3) without typical peritoneal metastasis indications in CT (diffuse omental nodules or omental cake, large amount of ascites, obvious irregular thickening with high peritoneal enhancement);
• (4) without other evidence of distant metastasis, and no stage IV features on CT.

Exclusion Criteria:

• (1) previous abdominal surgery;
• (2) previous abdominal malignancies or inflammatory diseases;
• (3) time intervals between CT and laparoscopy longer than 2 weeks;
• (4) CT image artifacts that undermine peritoneal lesion assessment.

Related Conditions & MeSH terms

• Gastric Cancer
• Neoplasm Metastasis
• Peritoneal Metastases
• Stomach Neoplasms

Intervention

Diagnostic Test:
• Peritoneal metastasis status ascertainment
Each participant with gastric cancer will undergo enhanced CT examination for detection of peritoneal metastasis. Within two weeks of CT examination, the participant will undergo diagnostic laparoscopy to confirm the status of peritoneal metastasis.

Locations

Country	Name	City	State
China	Peking University Cancer Hospital & Institute	Beijing
China	Fujian Medical University Union Hospital	Fuzhou
China	Affiliated Cancer Hospital and Institute of Guangzhou Medical University	Guangzhou
China	Guangdong Provincial People's Hospital	Guangzhou
China	Nanfang Hospital of Southern Medical University	Guangzhou
China	Sun Yat-Sen University Cancer Hospital	Guangzhou
China	Guizhou Provincial People's Hospital	Guiyang
China	Yunnan Cancer Hospital	Kunming
China	Shanxi Province Cancer Hospital	Taiyuan
China	Henan Cancer Hospital	Zhengzhou
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou
China	Zhenjiang First People's Hospital	Zhenjiang
Italy	Scientific Institute San Raffaele	Milan

Sponsors (15)

Lead Sponsor

Collaborator

Chinese Academy of Sciences

Beihang University, Fujian Medical University Union Hospital, Guangdong Provincial People's Hospital, Guangzhou Medical University, Guizhou Provincial People's Hospital, Henan Cancer Hospital, Nanfang Hospital of Southern Medical University, Peking University Cancer Hospital & Institute, Scientific Institute San Raffaele, Shanxi Province Cancer Hospital, Sun Yat-sen University, The First Affiliated Hospital of Zhengzhou University, Yunnan Cancer Hospital, Zhenjiang First People's Hospital

Countries where clinical trial is conducted

China,  Italy, 

References & Publications (5)

Ajani JA, D'Amico TA, Bentrem DJ, Chao J, Cooke D, Corvera C, Das P, Enzinger PC, Enzler T, Fanta P, Farjah F, Gerdes H, Gibson MK, Hochwald S, Hofstetter WL, Ilson DH, Keswani RN, Kim S, Kleinberg LR, Klempner SJ, Lacy J, Ly QP, Matkowskyj KA, McNamara M, Mulcahy MF, Outlaw D, Park H, Perry KA, Pimiento J, Poultsides GA, Reznik S, Roses RE, Strong VE, Su S, Wang HL, Wiesner G, Willett CG, Yakoub D, Yoon H, McMillian N, Pluchino LA. Gastric Cancer, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2022 Feb;20(2):167-192. doi: 10.6004/jnccn.2022.0008. — View Citation

Burbidge S, Mahady K, Naik K. The role of CT and staging laparoscopy in the staging of gastric cancer. Clin Radiol. 2013 Mar;68(3):251-5. doi: 10.1016/j.crad.2012.07.015. Epub 2012 Sep 14. — View Citation

Dong D, Tang L, Li ZY, Fang MJ, Gao JB, Shan XH, Ying XJ, Sun YS, Fu J, Wang XX, Li LM, Li ZH, Zhang DF, Zhang Y, Li ZM, Shan F, Bu ZD, Tian J, Ji JF. Development and validation of an individualized nomogram to identify occult peritoneal metastasis in pat — View Citation

Hur H, Lee HH, Jung H, Song KY, Jeon HM, Park CH. Predicting factors of unexpected peritoneal seeding in locally advanced gastric cancer: indications for staging laparoscopy. J Surg Oncol. 2010 Dec 1;102(7):753-7. doi: 10.1002/jso.21685. — View Citation

Smyth EC, Verheij M, Allum W, Cunningham D, Cervantes A, Arnold D; ESMO Guidelines Committee. Gastric cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2016 Sep;27(suppl 5):v38-v49. doi: 10.1093/annonc/mdw350. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The statistical significance of intelligent analysis system in risk stratification	Statistical significance (P value) of progression-free survival (PFS) in gastric cancer patients between high-risk and low-risk group identified by the intelligent analysis system.	Three years
Other	Progression-free survival time	The progression-free survival time in patient subgroups stratified by the intelligent analysis system.	Three years
Other	Overall survival	The overall survival time in patient subgroups stratified by the intelligent analysis system.	Three years
Primary	The aera under the receiver operating characteristic curve (AUC) of intelligent analysis system	AUC of the intelligent analysis system in predicting peritoneal metastasis for gastric cancer.	three months
Secondary	The accuray of intelligent analysis system in predicting peritoneal metastasis	The agreement between the prediction outcome of intelligent analysis system and the golden standard of peritoneal metastasis.	three months