Radiomics for Prediction of Lymph Node Metastasis in Gastric Cancer（RPLNM）(GIPMCS-1701)

Stomach Neoplasms Clinical Trial

Official title:

Radiomics for Prediction of Lymph Node Metastasis in Gastric Cancer（RPLNM）(GIPMCS-1701)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03488446
• Other study ID #: GIPMCS-1701
• Status: Recruiting
• First received: September 30, 2017
• Last updated: March 28, 2018
• Start date: August 30, 2017
• Est. completion date: March 31, 2019

Study information

• Verified date: August 2017
• Source: Nanfang Hospital of Southern Medical University
• Contact: Guoxin Li, M.D., PH.D.
• Phone: +86-138-0277-1450
• Email: gzliguoxin[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study proposes to establish a CT radiomics-based prediction model for identifying metastasis of each station lymph nodes in gastric cancer.

Description:

This is a prospective, multi-center trial conducted at 4 high-volume gastric cancer centers in China (Nanfang Hospital of Southern Medical University; Sun Yat-Sen University Cancer Center; First Affiliated Hospital, Sun Yat-Sen University; The Third Affiliated Hospital, Sun Yat-Sen University) designed to determine the predicted performance of radiomics-based prediction model for identifying metastasis of each station lymph nodes by enhanced CT for preoperative noninvasive assessment of the lymph node status in patients with gastric cancer. The study includes the construction of CT radiomics-based prediction model and the validation of the prediction model.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 31, 2019
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age >18 years;

• Patients providing written informed consent;

• Pathologically proven gastric cancer scheduled to preoperative enhanced abdomen CT and undergo gastrectomy with type D2 lymphadenectomy;

• Has undergone > 64 multi-detector row CT within 14 days prior to surgical resection; .No receipt of preoperative therapy (radiotherapy, chemotherapy or chemoradiotherapy).

Exclusion Criteria:

• Preoperative therapy (radiotherapy, chemotherapy or chemoradiotherapy);

• Failed to receive preoperative enhanced abdomen CT or undergo gastrectomy with type D2 lymphadenectomy;

• Inavailable pathological results for local lymph node status;

• Inquality of CT images for feature extraction; .Patient quit.

Related Conditions & MeSH terms

• Digestive System Diseases
• Digestive System Neoplasms
• Gastrointestinal Diseases
• Gastrointestinal Neoplasms
• Neoplasm Metastasis
• Neoplasms
• Stomach Neoplasms

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (5)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	First Affiliated Hospital, Sun Yat-Sen University, Sun Yat-sen University, The Third Affiliated Hospital of Southern Medical University, Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

Aerts HJ, Velazquez ER, Leijenaar RT, Parmar C, Grossmann P, Carvalho S, Bussink J, Monshouwer R, Haibe-Kains B, Rietveld D, Hoebers F, Rietbergen MM, Leemans CR, Dekker A, Quackenbush J, Gillies RJ, Lambin P. Decoding tumour phenotype by noninvasive imag — View Citation

Gillies RJ, Kinahan PE, Hricak H. Radiomics: Images Are More than Pictures, They Are Data. Radiology. 2016 Feb;278(2):563-77. doi: 10.1148/radiol.2015151169. Epub 2015 Nov 18. — View Citation

Huang YQ, Liang CH, He L, Tian J, Liang CS, Chen X, Ma ZL, Liu ZY. Development and Validation of a Radiomics Nomogram for Preoperative Prediction of Lymph Node Metastasis in Colorectal Cancer. J Clin Oncol. 2016 Jun 20;34(18):2157-64. doi: 10.1200/JCO.201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological lymph node status of every station	Pathological lymph node status of each station is defined as lymph node metastasis exist or not	Pathologic evaluation will be performed for each patient within 1 week after surgery
Secondary	Survival time	Disease-free survival and overall survival	Follow-up from the date of surgery to the date of death.
Secondary	Lymph node stage (N stage)	Pathological lymph node stage after surgery (N0 stage: no lymph node metastassis; N1 stage: 1-2 lymph node metastasis; N2 stage: 3-6 lymph node metastasis; N3a stage: 7-15 lymph node metastasis;N3b stage: >15 lymph node metastassis)	Pathologic evaluation will be performed for each patient within 1 week after surgery