CT and MRI in Prediction of Response in Patients With Gastric Cancer Following Neoadjuvant Chemotherapy and/or Immunotherapy

May 30, 2021 updated by: The First Hospital of Jilin University

Clinical Study of CT and MRI in Prediction of Response in Patients With Gastric Cancer Following Neoadjuvant Chemotherapy and/or Immunotherapy

This is a prospective and observational clinical study for seeking out a better way to predict the pathologic complete response (pCR) in patients with advanced gastric cancer (AGC) based on the post-neoadjuvant treatment Magnetic Resonance Imaging (MRI) and CT data. This study will help the surgeons to better formulate treatment regimens for gastric cancer in the clinical practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

With the gradual development of neoadjuvant immunotherapy and/or chemotherapy in the clinic, the pCR has become more and more accessible in the AGC. Preoperative accurate prediction of pCR is of great clinical significance. The contrast-enhanced CT and 3.0T MRI were carried out in patients within 1 week prior to commencing neoadjuvant treatment, as well as 1 week within surgery after the completion of neoadjuvant treatment, respectively. Based on the information extracted from the CT/MRI, the clinical completed response (cCR) and the clinical T staging were compared with pCR, pathologic T staging. The pathologic results were considered as the golden standard. With the ROC curve analysis, the diagnosis coincidence rate, sensitivity and specificity were assessed. The AI prediction model would be constructed and trained. The depth convolution neural network based on contrast-enhanced CT and multi-modal MR quantitative images which can automatically mine key images characterization, combined with imaging features and histopathologic response, could further help to improve the prediction of response of gastric cancer treated with systematic therapy. The abdominal contrast-enhanced CT will focus on parameters: Local T Staging, nodal status, diameter, according to RECIST 1.1. MRI T2 (1-3mm slice as per NS Radiology protocol and ESGAR guideline) will focus on parameters: DWI & ADC value (preferably on a single camera with reproducible ADC value), Local T Staging, MRF involvement, EMVI, nodal status, MR volumetry, and desmoplastic reaction.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with endoscopically biopsy-proven gastric cancer will receive preoperative neoadjuvant immunotherapy and/or chemotherapy.

Description

Inclusion Criteria:

  1. Age 18 Years to 80 Years
  2. Consecutive patients with preoperative pathologically confirmed AGC by endoscopy and preoperative imaging data (CT/MRI) were included.
  3. Clinical staging Ⅱ-Ⅲ according to the UICC/AJCC 8th guideline for gastric cancer without distant metastasis.
  4. Suitable for pre-operative chemotherapy, immunotherapy and surgical resection
  5. No contraindications for CT/MRI examination.
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  7. The patients participate in this study with informed consent.

Exclusion Criteria:

  1. Patients with a history of previous chemotherapy or immunotherapy.
  2. The patients couldn't perform MSCT or MR scanning or artefacts affect the evaluation.
  3. The patients are extremely anxious and uncooperative about surgery or neoadjuvant therapy.
  4. The patients refuse to participate in the project.
  5. Pregnancy, lactation or inadequate contraception
  6. Pacemaker or implanted defibrillator
  7. Patients with a history of psychological illness or condition such as to interfere with the patient's ability to understand requirements of the study.
  8. Other situations considered by investigators, which not meet the inclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Single Group Assignment
Patients with AGC who underwent neoadjuvant immunotherapy and/or chemotherapy would recieve MRI and CT examination before and after 3 cycles treatment.
Drug: PD-1 inhibitor
SOX regimen for 3 cycles and/or PD-1 inhibitor before surgery
Other Names:
  • Oxaliplatin
  • Tiggio

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Predictive value of CT and MRI after the neoadjuvant treatment for developing a pCR at surgery
Time Frame: up to 2 year
Predictive value of CT and MRI after the neoadjuvant treatment for developing a pathologic complete response at surgery (Grade 0 - no viable cancer cells seen in the resection specimen).
up to 2 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Predictive value of CT and MRI after the neoadjuvant treatment for pathologic T staging
Time Frame: up to 2 year
To evaluate the T staging of gastric cancer treated with neoadjuvant treatment through CT and MRI.
up to 2 year
Predictive value of CT and MRI after the neoadjuvant treatment for pathologic response according to the Tumor Regression Grading (TRG)
Time Frame: up to 2 year
Pathological tumour regression grading (Mandard criterion): from 1 to 5 grading.
up to 2 year
Prediction model based on CT and MRI of response in AGC
Time Frame: up to 2 year
To construct a model, a depth convolution neural network based on contrast-enhanced CT and multi-modal MR quantitative images which can automatically mine key images characterization, combined with imaging features and histopathologic response, could further help to improve the prediction of response of gastric/rectal cancer treated with systematic therapy.
up to 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Hospital of Jilin University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: quan wang, MD, The First Hospital of Jilin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 4, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STARS-GC03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no share

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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