Esophageal CancerNCT06755866
DCE-MRI Based on 4D Free Breathing for Predicting Preoperative Neoadjuvant Chemoradiotherapy for Esophageal Cancer
A study testing The application value of MRI 4D Free Breathing DCE-MRI in the treatment of esophageal cancer in people with Esophageal Cancer, run by Yunnan Cancer Hospital at 1 site in China.
Trial summary
To prospectively collect medical images and clinical data related to esophageal cancer using 4D Free Breathing DCE-MRI technology, to evaluate the image quality in the diagnosis of esophageal cancer, and to predict the efficacy of preoperative neoadjuvant chemoradiotherapy for esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- The application value of MRI 4D Free Breathing DCE-MRI in the treatment of esophageal cancer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteChina
- Study dates
- 26 Nov 2024to 31 Jul 2026
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be 18 years of age and older;
- First diagnosis of esophageal squamous cell carcinoma confirmed by histopathological biopsy;
- The clinical stage is cT1b~cT2N+; or the clinical stage is cT3~cT4 any N, (thoracic esophageal cancer, esophagogastric junction cancer);
- There are no contraindications to MRI examination
Who cannot join
- Have other primary tumors;
- The image quality does not meet the diagnostic criteria;
- Those who do not cooperate with the inspection;
- Patients who have received prior chemoradiotherapy
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
Yunnan Cancer Hospital
Kunming, Yunnan
Guojun Zhang, r 0871-68173640
About this study
To prospectively collect medical images and clinical data related to esophageal cancer using 4D Free Breathing DCE-MRI technology, to evaluate the image quality in the diagnosis of esophageal cancer, and to predict the efficacy of preoperative neoadjuvant chemoradiotherapy for esophageal cancer.
- Conditions
- Esophageal Cancer
- Being tested
- The application value of MRI 4D Free Breathing DCE-MRI in the treatment of esophageal cancer
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The application value of MRI 4D Free Breathing DCE-MRI in the treatment of esophageal cancerDiagnostic test
Chest MRI scan outside of standard treatment options
| Study group | Role | What they receive |
|---|---|---|
| Application of DCE-MRI based on 4D Free Breathing in predicting the efficacy of preoperative neoadju | Experimental | Prospective collection uses a Philips 3.0T MRI scanner equipped with a dStream Torso 32-channel coil. DCE-MRI was performed using a free respiration sequence with a flow rate of 3.0 m/s. The medical images and clinical data related to esophageal cancer using 4D Free Breathing DCE-MRI technology were performed by two radiologists (one with 3 years of diagnostic experience and the other with 15 years of diagnostic experience), including subjective and objective assessment of image quality in the diagnosis of esophageal cancer, and the use of this technology to predict the efficacy of preoperative neoadjuvant chemoradiotherapy for esophageal cancer with pathological PCR as the outcome. Receives: Diagnostic Test: The application value of MRI 4D Free Breathing DCE-MRI in the treatment of esophageal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response assessment
This study aims to assess tumor treatment response using pathology gold standard pCR . pCR refers to the state in which the pathological tumor completely disappears after systemic therapy, such as chemotherapy, targeted therapy, or endocrine therapy.
Measured: Surgery was performed within one month after neoadjuvant therapy, and the pathological pCR of the pathological results obtained from the surgery was used as the gold standard in this study to evaluate tumor treatment response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start26 Nov 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yunnan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lianhua Ye, Study director, Ethics Committee of Yunnan Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755866
- Sponsor's protocol ID
- KYLX2024-273
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DCE-MRI Based on 4D Free Breathing for Predicting Preoperative Neoadjuvant Chemoradiotherapy for Esophageal Cancer
- ClinicalTrials.gov ID
- NCT06755866
- Acronym / sponsor ID
- KYLX2024-273
- Conditions
- Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Yunnan Cancer HospitalUniversity, hospital or other
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 1 Jan 2025 (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.
To prospectively collect medical images and clinical data related to esophageal cancer using 4D Free Breathing DCE-MRI technology, to evaluate the image quality in the diagnosis of esophageal cancer, and to predict the efficacy of preoperative neoadjuvant chemoradiotherapy for esophageal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Application of DCE-MRI based on 4D Free Breathing in predicting the efficacy of preoperative neoadju | Experimental | Diagnostic Test: The application value of MRI 4D Free Breathing DCE-MRI in the treatment of esophageal cancerProspective collection uses a Philips 3.0T MRI scanner equipped with a dStream Torso 32-channel coil. DCE-MRI was performed using a free respiration sequence with a flow rate of 3.0 m/s. The medical images and clinical data related to esophageal cancer using 4D Free Breathing DCE-MRI technology were performed by two radiologists (one with 3 years of diagnostic experience and the other with 15 years of diagnostic experience), including subjective and objective assessment of image quality in the diagnosis of esophageal cancer, and the use of this technology to predict the efficacy of preoperative neoadjuvant chemoradiotherapy for esophageal cancer with pathological PCR as the outcome. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be 18 years of age and older;
- First diagnosis of esophageal squamous cell carcinoma confirmed by histopathological biopsy;
- The clinical stage is cT1b~cT2N+; or the clinical stage is cT3~cT4 any N, (thoracic esophageal cancer, esophagogastric junction cancer);
- There are no contraindications to MRI examination
Key exclusion criteria (4 listed)
- Have other primary tumors;
- The image quality does not meet the diagnostic criteria;
- Those who do not cooperate with the inspection;
- Patients who have received prior chemoradiotherapy
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 |
|---|---|---|
| The application value of MRI 4D Free Breathing DCE-MRI in the treatment of esophageal cancerChest MRI scan outside of standard treatment options | Diagnostic test | Application of DCE-MRI based on 4D Free Breathing in predicting the efficacy of preoperative neoadju |
Primary outcome
Tumor response assessment
Time frame: Surgery was performed within one month after neoadjuvant therapy, and the pathological pCR of the pathological results obtained from the surgery was used as the gold standard in this study to evaluate tumor treatment response
This study aims to assess tumor treatment response using pathology gold standard pCR . pCR refers to the state in which the pathological tumor completely disappears after systemic therapy, such as chemotherapy, targeted therapy, or endocrine therapy.
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 1 Jan 2025.
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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.
Lianhua Ye study director
Ethics Committee of Yunnan Provincial Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The application value of MRI 4D Free Breathing DCE-MRI in the treatment of esophageal cancer in people with Esophageal Cancer, run by Yunnan Cancer Hospital 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 4 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 1 Jan 2025. 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?
Contact ruiling Yang (17390212095, 1516559633@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response assessment (time frame: Surgery was performed within one month after neoadjuvant therapy, and the pathological pCR of the pathological results obtained from the surgery was used as the gold standard in this study to evaluate tumor treatment response). 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 1 Jan 2025.