Clinical Trials Logo
  1. Home
  2. Pancreatic Neoplasms
  3. NCT06336694
  4. Details
NCT06336694 Clinical Trial

A Deep Learning Radiomics Model for Predicting Occult Peritoneal Metastases of Pancreatic Adenocarcinoma

Pancreatic Neoplasms Clinical Trial

Official title:
Development and Validation of a Deep Learning Radiomics Model With Clinical-radiological Characteristics for the Identification of Occult Peritoneal Metastases in Patients With Pancreatic Ductal Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06336694
Other study ID # SYSUFAH2021-025
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date July 30, 2023

Study information
Verified date March 2024
Source First Affiliated Hospital, Sun Yat-Sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Occult peritoneal metastases (OPM) in patients with pancreatic ductal adenocarcinoma (PDAC) are frequently overlooked during imaging. We aimed to develop and validate a CT-based deep learning-based radiomics (DLR) model with clinical-radiological characteristics to identify OPM in patients with PDAC before treatment.

Description:

This retrospective, bicentric study included 302 patients with PDAC (training: n = 167, OPM-positive, n=22; internal test: n = 72, OPM-positive, n=9: external test, n=63, OPM-positive, n=9) who had undergone baseline CT examinations between January 2012 and October 2022. Handcrafted radiomics (HCR) and DLR features of the tumor and HCR features of peritoneum were extracted from CT images. Mutual information and least absolute shrinkage and selection operator algorithms were used for feature selection. A combined model, which incorporated the selected clinical-radiological, HCR, and DLR features, was developed using a logistic regression classifier using data from the training cohort and validated in the test cohorts.

Recruitment information / eligibility
Status Completed
Enrollment 302
Est. completion date July 30, 2023
Est. primary completion date October 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Patients with suspected pancreatic tumors who underwent contrast enhanced CT and pathological examinations at Center 1 and Center 2 were eligible for inclusion in this study. Exclusion Criteria: - (a) pathologically diagnosed PDAC by pathology, (b) time intervals between contrast-enhanced CT and pathology less than 2 weeks; (c) history of pancreatic surgery, (d) history of pancreatic malignancy, and (e) poor CT image quality that undermined peritoneal lesion assessment

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• surgery or diagnostic staging laparoscopy
diagnosis of PDAC with peritoneal examination based on the surgical (for tumors treated with surgery) or diagnostic staging laparoscopy findings (for tumors treated with radiotherapy/chemotherapy)

Locations
Country Name City State
China Shi Siya Guangzhou Guangdong

Sponsors (1)
Lead Sponsor Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary diagnosed with peritoneal metastases percentage immediately after the surgery
See also
  Status Clinical Trial Phase
Recruiting NCT04085055 - Fine Needle Biopsy of Solid Pancreatic Mass Lesions N/A
Recruiting NCT01950572 - Tissue Procurement and Natural History Study of Patients With Malignant Mesothelioma
Terminated NCT00529113 - Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer Phase 1
Recruiting NCT05351983 - Patient-derived Organoids Drug Screen in Pancreatic Cancer N/A
Recruiting NCT04809935 - EUS-Coeliac Plexus Block Versus Radiofrequency Ablation in Pain Relief of Patients With Malignancy Phase 4
Recruiting NCT05481476 - Surufatinib Combined With Sintilimab and AG in First-line Therapy of Patients With Locally Advanced or Metastatic Pancreatic Cancer Phase 2
Not yet recruiting NCT04652271 - International Pancreatic Surgery Outcomes Study - PancreasGroup.Org
Active, not recruiting NCT02950064 - A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations Phase 1
Completed NCT02909530 - Comparison Between Olympus EZ Shot 3Plus 19G and EZ Shot 2 19G in EUS-guided FNB of Solid Pancreatic Masses N/A
Completed NCT03054987 - Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography for Malignant Distal Biliary Obstruction N/A
Completed NCT02374411 - Knowledge, Attitudes, and Practice of Surgeons Toward Nutrition Support in HIPEC Patients N/A
Completed NCT01770405 - Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract N/A
Terminated NCT01313416 - Gemcitabine and CT-011 for Resected Pancreatic Cancer Phase 2
Terminated NCT01515046 - Clinical Trial of High-dose Vitamin C for Advanced Pancreatic Cancer Phase 2
Enrolling by invitation NCT01465425 - Extracolonic Findings on Computed Tomography (CT) Colonography
Terminated NCT01434459 - Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin Phase 1
Completed NCT00985777 - Vitamin E δ-Tocotrienol Administered to Subjects With Resectable Pancreatic Exocrine Neoplasia Phase 1
Completed NCT00385177 - Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors Phase 1
Recruiting NCT00178763 - Hyperthermia With Chemotherapy for Locally Advanced or Metastatic Pancreas Cancer Phase 2
Completed NCT00196105 - Malignant Obstruction ZILVER Against Routine Therapy (MOZART I) N/A