Gastric Cancer StageNCT05508126
Multi-parametric MRI and Dual-energy CT in Patients of Gastric Cancer
An observational study of Gastric Cancer Stage, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Accurate preoperative staging of gastric cancer is of major importance for guiding therapeutic decision-making, preventing both under- and over-treatment. The purpose of this study is to investigate the diagnostic performance of the Multi-parametric magnetic resonance imaging (mpMRI) and dual-energy computed… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer Stage
- What is being tested?
- DECT examination and mpMRI examination
- How many people
- 222 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients diagnosed with gastric cancer by endoscopically biopsy will be considered for inclusion in the study.
Who may be able to join
- Consecutive patients with preoperative pathologically confirmed GC by endoscopy and preoperative imaging data (DECT/mpMRI) were included.
- No contraindications for CT/MRI examination
- Written informed consent
Who cannot join
- Patients with a history of previous therapy.
- Patients with recurrent gastric cancer
- Patients with a history of severe allergy to contrast agents
- Patients with imaging artefacts affect the evaluation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yu-Dong Zhang
Nanjing, 210029
Yu-Dong Zhang, MD;PHD, 15805151704, njmu_zyd@163.com
About this study
Official title: Diagnostic Accuracy of Multi-parametric MRI and Dual-energy CT in Gastric Cancer: a Paired Validating Confirmatory Study
Accurate preoperative staging of gastric cancer is of major importance for guiding therapeutic decision-making, preventing both under- and over-treatment. The purpose of this study is to investigate the diagnostic performance of the Multi-parametric magnetic resonance imaging (mpMRI) and dual-energy computed tomography (DECT) in gastric cancer.
Read the detailed description
Gastric cancer is the leading cause of cancer-related death worldwide. The therapeutic approach to gastric cancer is strongly dependent on preoperative stage. The crucial role of gastric cancer imaging lies in implementing individualized treatment regimens according to various stages of tumor.
CT scanning has been recommended as the first-line image modality for preoperative evaluation of gastric cancer by the 8th AJCC staging manual. However, for traditional CT, the accuracy of staging is highly variable and the sensitivity of early gastric cancer detection is relatively low. Recently, DECT has been increasingly used in clinical practice due to its powerful post-processing technique. A recent small sample study showed that monoenergetic images at 40 KeV improved lesion depiction and higher T stage accuracy for gastric cancer. Therefore, this study chose DECT instead of traditional CT to explore the diagnostic performance in preoperative staging.
Historically, the role of MRI in gastric cancer has been limited, and the guidelines have not yet recommended MRI as a first-line examination scheme. But with the continuous technical improvements for abdominal imaging (e.g. breath-hold sequences and high Resolution diffusion-weighted imaging (DWI), free-breathing dynamic contrast-enhanced (DCE) sequence), mpMRI has become a promising imaging technology. In addition, given the advantages of non-radiation, non-invasiveness, and excellent soft tissue contrast, mpMRI may be more suitable for neoadjuvant therapy patients who require multiple evaluations.
Patients with gastric cancer confirmed by endoscopic biopsy will be prospectively included in this study. Patients undergo both mpMRI and DECT at baseline to stage the primary tumor, regional lymph nodes, and to rule out distant sites of disease. The interval between mpMRI and DECT examinations should not exceed 7 days. All patients will be treated according to standard practice in our institution. Patients receiving neoadjuvant chemotherapy will undergo mpMRI and DECT scan again for restaging. The postoperative pathology results of these two examination methods were prospectively collected, and their efficacy was calculated according to the reference standard. After completion of study intervention, patients are followed up periodically.
- Conditions
- Gastric Cancer Stage
- Being tested
- DECT examination, mpMRI examination
- Keywords
- Computed Tomography, Magnetic Resonance Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DECT examinationDiagnostic test
DECT examinations will be performed using a 192-slice CT scanner (SOMATOM, Force, Siemens, Forchheim, Germany).
mpMRI examinationDiagnostic test
The examinations were conducted on a 3-T MR scanner (MAGNETOM Skyra; Siemens Healthcare, Erlangen, Germany).
| Study group | Role | What they receive |
|---|---|---|
| Primary staging group I | All patients will be treated according to standard practice. Patients in group I are patients that will be stratified for radical gastrectomy or endoscopic resection. Group I will undergo only a primary staging. All patients will take DECT and mpMRI examination within 1 week before surgery. Receives: Diagnostic Test: DECT examination; Diagnostic Test: mpMRI examination | |
| Restaging group II | Patients in group II are patients that will be stratified for neoadjuvant chemotherapy.
Group II will undergo a primary staging (DECT and mpMRI) and 1-2 times restaging (DECT and mpMRI). Receives: Diagnostic Test: DECT examination; Diagnostic Test: mpMRI examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of DECT and mpMRI in tumor staging assessment
Accuracy for both imaging techniques in the prediction of tumor staging.
Measured: 2 years
Diagnostic performance of DECT and mpMRI in tumor restaging assessment
Accuracy for both imaging techniques in the prediction of tumor restaging.
Measured: 2 years
Secondary outcomes (7)
The kappa value
Inter-rater reliability of the DECT and mpMRI in tumor assessment
Measured: 2 years
Predictive value of DECT and mpMRI after the neoadjuvant treatment for pathologic response
Pathological tumour regression grading (Mandard criterion): from 1 to 5 grading.
Measured: 4 years
Disease free survival (DFS)
Survival analysis: Radiologic data predicting DFS.
Measured: 4 years
Overall survival (OS)
Survival analysis: Radiologic data predicting OS.
Measured: 5 years
Likert scales 1-5
Qualitative image analysis of mpMRI in a supine and prone position
Measured: 6 months
The signal-to-noise Ratio (SNR)
Quantitative image analysis of mpMRI in a supine and prone position.
Measured: 6 months
Contrast-to-noise Ratio (CNR)
Quantitative image analysis of mpMRI in a supine and prone position.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Nov 2021
- Primary completion1 Jun 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastric Cancer StageStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 222 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508126
- Sponsor's protocol ID
- 2021-SR-475
- Status last verified
- Oct 2024
- First submitted
- 11 Aug 2022
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhen Y, Xie Q, Liu L. Diagnostic Value of Spiral CT and Magnetic Resonance Imaging Scanning in Gastric Cancer and Precancerous Lesions. Scanning. 2022 May 23;2022:3627385. doi: 10.1155/2022/3627385. eCollection 2022.
PubMed 35795615Giganti F, Orsenigo E, Arcidiacono PG, Nicoletti R, Albarello L, Ambrosi A, Salerno A, Esposito A, Petrone MC, Chiari D, Staudacher C, Del Maschio A, De Cobelli F. Preoperative locoregional staging of gastric cancer: is there a place for magnetic resonance imaging? Prospective comparison with EUS and multidetector computed tomography. Gastric Cancer. 2016 Jan;19(1):216-25. doi: 10.1007/s10120-015-0468-1. Epub 2015 Jan 23.
PubMed 25614468Borggreve AS, Goense L, Brenkman HJF, Mook S, Meijer GJ, Wessels FJ, Verheij M, Jansen EPM, van Hillegersberg R, van Rossum PSN, Ruurda JP. Imaging strategies in the management of gastric cancer: current role and future potential of MRI. Br J Radiol. 2019 May;92(1097):20181044. doi: 10.1259/bjr.20181044. Epub 2019 Mar 5.
PubMed 30789792
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of Multi-parametric MRI and Dual-energy CT in Gastric Cancer: a Paired Validating Confirmatory Study
- ClinicalTrials.gov ID
- NCT05508126
- Acronym / sponsor ID
- 2021-SR-475
- Conditions
- Gastric Cancer Stage
- Keywords
- Computed Tomography, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Accurate preoperative staging of gastric cancer is of major importance for guiding therapeutic decision-making, preventing both under- and over-treatment. The purpose of this study is to investigate the diagnostic performance of the Multi-parametric magnetic resonance imaging (mpMRI) and dual-energy computed tomography (DECT) in gastric cancer.
Detailed description
Gastric cancer is the leading cause of cancer-related death worldwide. The therapeutic approach to gastric cancer is strongly dependent on preoperative stage. The crucial role of gastric cancer imaging lies in implementing individualized treatment regimens according to various stages of tumor.
CT scanning has been recommended as the first-line image modality for preoperative evaluation of gastric cancer by the 8th AJCC staging manual. However, for traditional CT, the accuracy of staging is highly variable and the sensitivity of early gastric cancer detection is relatively low. Recently, DECT has been increasingly used in clinical practice due to its powerful post-processing technique. A recent small sample study showed that monoenergetic images at 40 KeV improved lesion depiction and higher T stage accuracy for gastric cancer. Therefore, this study chose DECT instead of traditional CT to explore the diagnostic performance in preoperative staging.
Historically, the role of MRI in gastric cancer has been limited, and the guidelines have not yet recommended MRI as a first-line examination scheme. But with the continuous technical improvements for abdominal imaging (e.g. breath-hold sequences and high Resolution diffusion-weighted imaging (DWI), free-breathing dynamic contrast-enhanced (DCE) sequence), mpMRI has become a promising imaging technology. In addition, given the advantages of non-radiation, non-invasiveness, and excellent soft tissue contrast, mpMRI may be more suitable for neoadjuvant therapy patients who require multiple evaluations.
Patients with gastric cancer confirmed by endoscopic biopsy will be prospectively included in this study. Patients undergo both mpMRI and DECT at baseline to stage the primary tumor, regional lymph nodes, and to rule out distant sites of disease. The interval between mpMRI and DECT examinations should not exceed 7 days. All patients will be treated according to standard practice in our institution. Patients receiving neoadjuvant chemotherapy will undergo mpMRI and DECT scan again for restaging. The postoperative pathology results of these two examination methods were prospectively collected, and their efficacy was calculated according to the reference standard. After completion of study intervention, patients are followed up periodically.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary staging group I | – | Diagnostic Test: DECT examination, Diagnostic Test: mpMRI examinationAll patients will be treated according to standard practice. Patients in group I are patients that will be stratified for radical gastrectomy or endoscopic resection. Group I will undergo only a primary staging. All patients will take DECT and mpMRI examination within 1 week before surgery. |
| Restaging group II | – | Diagnostic Test: DECT examination, Diagnostic Test: mpMRI examinationPatients in group II are patients that will be stratified for neoadjuvant chemotherapy. Group II will undergo a primary staging (DECT and mpMRI) and 1-2 times restaging (DECT and mpMRI). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed with gastric cancer by endoscopically biopsy will be considered for inclusion in the study.
Key inclusion criteria (3 listed)
- Consecutive patients with preoperative pathologically confirmed GC by endoscopy and preoperative imaging data (DECT/mpMRI) were included.
- No contraindications for CT/MRI examination
- Written informed consent
Key exclusion criteria (4 listed)
- Patients with a history of previous therapy.
- Patients with recurrent gastric cancer
- Patients with a history of severe allergy to contrast agents
- Patients with imaging artefacts affect the evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DECT examinationDECT examinations will be performed using a 192-slice CT scanner (SOMATOM, Force, Siemens, Forchheim, Germany). | Diagnostic test | Primary staging group I, Restaging group II |
| mpMRI examinationThe examinations were conducted on a 3-T MR scanner (MAGNETOM Skyra; Siemens Healthcare, Erlangen, Germany). | Diagnostic test | Primary staging group I, Restaging group II |
Primary outcome
Diagnostic performance of DECT and mpMRI in tumor staging assessment
Time frame: 2 years
Accuracy for both imaging techniques in the prediction of tumor staging.
Diagnostic performance of DECT and mpMRI in tumor restaging assessment
Time frame: 2 years
Accuracy for both imaging techniques in the prediction of tumor restaging.
7 secondary outcomes
The kappa value
Time frame: 2 years
Predictive value of DECT and mpMRI after the neoadjuvant treatment for pathologic response
Time frame: 4 years
Disease free survival (DFS)
Time frame: 4 years
Overall survival (OS)
Time frame: 5 years
Likert scales 1-5
Time frame: 6 months
The signal-to-noise Ratio (SNR)
Time frame: 6 months
Contrast-to-noise Ratio (CNR)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 35795615Zhen Y, Xie Q, Liu L. Diagnostic Value of Spiral CT and Magnetic Resonance Imaging Scanning in Gastric Cancer and Precancerous Lesions. Scanning. 2022 May 23;2022:3627385. doi: 10.1155/2022/3627385. eCollection 2022.
- Background: PubMed 25614468Giganti F, Orsenigo E, Arcidiacono PG, Nicoletti R, Albarello L, Ambrosi A, Salerno A, Esposito A, Petrone MC, Chiari D, Staudacher C, Del Maschio A, De Cobelli F. Preoperative locoregional staging of gastric cancer: is there a place for magnetic resonance imaging? Prospective comparison with EUS and multidetector computed tomography. Gastric Cancer. 2016 Jan;19(1):216-25. doi: 10.1007/s10120-015-0468-1. Epub 2015 Jan 23.
- Background: PubMed 30789792Borggreve AS, Goense L, Brenkman HJF, Mook S, Meijer GJ, Wessels FJ, Verheij M, Jansen EPM, van Hillegersberg R, van Rossum PSN, Ruurda JP. Imaging strategies in the management of gastric cancer: current role and future potential of MRI. Br J Radiol. 2019 May;92(1097):20181044. doi: 10.1259/bjr.20181044. Epub 2019 Mar 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer Stage, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of DECT and mpMRI in tumor staging assessment (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05508126, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.