Gastric Cancer, Gastroesophageal Junction CancerNCT06640153
MRI and CT in Gastroesophageal Junction or Upper Gastric Adenocarcinoma
An observational study of Gastric Cancer, Gastroesophageal Junction Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Accurate preoperative Siewert classification, precise assessment of the extent of esophageal involvement, and staging is crucial for determining the appropriate surgical approach and achieving negative resection margins. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Cancer
- What is being tested?
- mpMRI
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2024to 24 Aug 2027
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with gastroesophageal junction or upper gastric adenocarcinoma who are candidates for radical surgical intervention.
Who may be able to join
- patients with gastric cancer confirmed by preoperative gastroscopic biopsy;
- underwent standardized mpMRI and CT examination;
- patients with complete postoperative pathological data and pathological results of gastroesophageal Junction or upper gastric adenocarcinoma;
Who cannot join
- combined with other tumors;
- Clinical and imaging data were missing or could not meet the research needs;
- the location of lesions could not be determined;
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu
About this study
Official title: Preoperative Evaluation of Resectability in Gastroesophageal Junction and Upper Gastric Adenocarcinoma Utilizing Multi-Parametric MRI and CT Imaging.
Accurate preoperative Siewert classification, precise assessment of the extent of esophageal involvement, and staging is crucial for determining the appropriate surgical approach and achieving negative resection margins. The purpose of this study is to investigate the diagnostic performance of the Multi-parametric magnetic resonance imaging (mpMRI) and computed tomography (CT) in gastroesophageal junction and upper gastric cancers.
Read the detailed description
Despite a continuous decline in the incidence of gastric cancer in recent years, the morbidity and mortality rates associated with the gastroesophageal junction and upper gastric cancers remain elevated. Consequently, it is imperative to develop more refined and individualized precision strategies for screening, diagnosis, surgical intervention, and comprehensive treatment. Due to the unique anatomical location, considerable debate exists regarding the critical aspects of its surgical management in clinical practice. Multiparametric MRI offers significant anatomical benefits due to its high soft tissue resolution, and its functional imaging capabilities present promising applications. With advancements in abdominal imaging technology, novel techniques such as high-order diffusion imaging and compressed sensing technology have facilitated high-resolution MRI of the stomach during free breathing, which is now implemented in clinical practice. Prior research has demonstrated that individualized gastric MRI scanning consistently yields superior image quality, and MRI provides greater accuracy than CT in preoperative staging assessments. Nonetheless, the comparative study of MRI and CT in patients with gastroesophageal junction and upper gastric cancers remains to be elucidated.
- Being tested
- mpMRI
- Keywords
- MR, CT, Adenocarcinoma of the Gastroesophageal Junction, Gastric Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mpMRIDiagnostic test
Gastroesophageal junction or upper gastric adenocarcinoma patients undergo mpMRI at siewert classification, length of esophageal involvement, primary staging and restaging
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Gastroesophageal junction or upper gastric adenocarcinoma | Patients with biopsy verified gastroesophageal junction or upper gastric adenocarcinoma undergo mpMRI in addition to conventional CT imaging Receives: Diagnostic Test: mpMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Siewert classification
Compare the findings of multiparametric MRI and CT in the Siewert classification (Types I, II, and III) against a histopathological reference standard, evaluating sensitivity, specificity, positive predictive value, and negative predictive value.
Measured: 2 years
length of esophageal involvement
The accuracy and AUC of length of esophageal involvement (not involved, 0-2cm, 2-3cm, 3-4cm, >4cm) evaluated by CT and MRI.
Measured: 2 years
Staging
Compare the cancer stage (according to AJCC 8th edition TNM-classification) as determined by mpMRI compared to CT at primary staging and at restaging. The proportion of upgraded, downgraded, and right patients are determined.
Measured: 2 years
Secondary outcomes (2)
Survival time and recurrence time
3-year overall survival
1-year and 3-year recurrence free survival
Measured: 3 years
The number of patients with complications
The morbidity and mortality rates within 30 days after the day of operation
Measured: Within 30 days after the day of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start21 Aug 2024
- Primary completion24 Aug 2025 (estimated)
- Study completion24 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer, Gastroesophageal Junction CancerStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640153
- Sponsor's protocol ID
- 2024-SR-587
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Preoperative Evaluation of Resectability in Gastroesophageal Junction and Upper Gastric Adenocarcinoma Utilizing Multi-Parametric MRI and CT Imaging.
- ClinicalTrials.gov ID
- NCT06640153
- Acronym / sponsor ID
- 2024-SR-587
- Keywords
- MR, CT, Adenocarcinoma of the Gastroesophageal Junction, Gastric Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 24 Aug 2025 (estimated)
- Study completion
- 24 Aug 2027 (estimated)
- First posted
- 15 Oct 2024 (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 Siewert classification, precise assessment of the extent of esophageal involvement, and staging is crucial for determining the appropriate surgical approach and achieving negative resection margins. The purpose of this study is to investigate the diagnostic performance of the Multi-parametric magnetic resonance imaging (mpMRI) and computed tomography (CT) in gastroesophageal junction and upper gastric cancers.
Detailed description
Despite a continuous decline in the incidence of gastric cancer in recent years, the morbidity and mortality rates associated with the gastroesophageal junction and upper gastric cancers remain elevated. Consequently, it is imperative to develop more refined and individualized precision strategies for screening, diagnosis, surgical intervention, and comprehensive treatment. Due to the unique anatomical location, considerable debate exists regarding the critical aspects of its surgical management in clinical practice. Multiparametric MRI offers significant anatomical benefits due to its high soft tissue resolution, and its functional imaging capabilities present promising applications. With advancements in abdominal imaging technology, novel techniques such as high-order diffusion imaging and compressed sensing technology have facilitated high-resolution MRI of the stomach during free breathing, which is now implemented in clinical practice. Prior research has demonstrated that individualized gastric MRI scanning consistently yields superior image quality, and MRI provides greater accuracy than CT in preoperative staging assessments. Nonetheless, the comparative study of MRI and CT in patients with gastroesophageal junction and upper gastric cancers remains to be elucidated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Gastroesophageal junction or upper gastric adenocarcinoma | – | Diagnostic Test: mpMRIPatients with biopsy verified gastroesophageal junction or upper gastric adenocarcinoma undergo mpMRI in addition to conventional CT imaging |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with gastroesophageal junction or upper gastric adenocarcinoma who are candidates for radical surgical intervention.
Key inclusion criteria (3 listed)
- patients with gastric cancer confirmed by preoperative gastroscopic biopsy;
- underwent standardized mpMRI and CT examination;
- patients with complete postoperative pathological data and pathological results of gastroesophageal Junction or upper gastric adenocarcinoma;
Key exclusion criteria (3 listed)
- combined with other tumors;
- Clinical and imaging data were missing or could not meet the research needs;
- the location of lesions could not be determined;
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 |
|---|---|---|
| mpMRIGastroesophageal junction or upper gastric adenocarcinoma patients undergo mpMRI at siewert classification, length of esophageal involvement, primary staging and restaging | Diagnostic test | Experimental: Gastroesophageal junction or upper gastric adenocarcinoma |
Primary outcome
Siewert classification
Time frame: 2 years
Compare the findings of multiparametric MRI and CT in the Siewert classification (Types I, II, and III) against a histopathological reference standard, evaluating sensitivity, specificity, positive predictive value, and negative predictive value.
length of esophageal involvement
Time frame: 2 years
The accuracy and AUC of length of esophageal involvement (not involved, 0-2cm, 2-3cm, 3-4cm, >4cm) evaluated by CT and MRI.
Staging
Time frame: 2 years
Compare the cancer stage (according to AJCC 8th edition TNM-classification) as determined by mpMRI compared to CT at primary staging and at restaging. The proportion of upgraded, downgraded, and right patients are determined.
2 secondary outcomes
Survival time and recurrence time
Time frame: 3 years
The number of patients with complications
Time frame: Within 30 days after the day of operation
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.
- Individual participant dataSharing planned: No
Related trials for Gastric Cancer, Gastroesophageal Junction Cancer
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 2
Perioperative Cadonilimab (AK104) in Locally Advanced MSI-H/dMMR Gastric or Gastroesophageal Junction and Colorectal Adenocarcinoma
MSI-H/dMMR Gastric Carcinoma and Colorectal Cancer
RecruitingPhase 2
Candonilimab Combined With Fruquintinib and Paclitaxel Albumin-Bound as Second-Line Treatment for Advanced Gastric or Gastro-esophageal Junction Adenocarcinoma
Stomach Neoplasms
RecruitingPhase 1/2
Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread
Metastatic Breast Cancer, Metastatic Gastric Adenocarcinoma
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, Gastroesophageal Junction Cancer, 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 3 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: under way, not looking for participants, 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Siewert classification (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.