Prediction of Peritoneal Metastasis for Gastric Cancer Based on Radiomics

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

• The aera under the receiver operating characteristic curve (AUC) of intelligent analysis system [Срок оценки: three months]

Вторичные конечные точки (1)

• The accuray of intelligent analysis system in predicting peritoneal metastasis [Срок оценки: three months]

Критерии участия

Критерии включения

• (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.

Критерии исключения

• (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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 12 центров

• Peking University Cancer Hospital & Institute — Пекин
• Fujian Medical University Union Hospital — Фучжоу
• Affiliated Cancer Hospital and Institute of Guangzhou Medical University — Гуанчжоу
• Guangdong Provincial People's Hospital — Гуанчжоу
• Nanfang Hospital of Southern Medical University — Гуанчжоу
• Sun Yat-Sen University Cancer Hospital — Гуанчжоу
• Guizhou Provincial People's Hospital — Guiyang
• Yunnan Cancer Hospital — Куньмин
• … и ещё 4 центра

Италия · 1 центр

• Scientific Institute San Raffaele — Milan

Публикации

• 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. PMID 27664260
• 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 PMID 35130500
• 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. PMID 20812349
• 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. PMID 22985749
• 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 patients with advanced gastric cancer. Ann Oncol. 2019 Mar 1;30(3):431-438. doi: 10.1093/annonc/mdz001. PMID 30689702

Идентификаторы

NCT: NCT05722275 · CASMI003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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