Esophageal CancerEscapeNCT04359732
Assessment of Response to nCRT for GEJ Cancer Using a Fully Integrated PET/MRI
A study testing hybrid PET/MRI in people with Esophageal Cancer and Esophageal Neoplasms, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Evaluate the potential role of PET/MRI as a predictor of esophageal and junctional cancers in response to neoadjuvant chemoradiotherapy (nCRT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer, Esophageal Neoplasms
- What is being tested?
- hybrid PET/MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteItaly
- Study dates
- 10 May 2020to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- biopsy-proven esophageal or junctional carcinomas (either adenocarcinoma (AC) or squamous cell carcinoma (SCC) for which an Ivor-Lewis transthoracic esophagectomy with supramesocolic and mediastinal lymphadenectomy is indicated;
- visible tumor on pre-treatment imaging;
- ≥ 18 years of age;
- signed informed consent.
Who cannot join
- - incomplete preoperative imaging assessment;
- contraindications to neoadjuvant treatment;
- contraindications to preoperative imaging (such as pacemaker, allergy to contrast agents);
- inability to complete imaging examinations (i.e. severe claustrophobia);
- contraindication to surgery (comorbidities, distant metastatic disease (imaging confirmed));
- pregnant or lactating women
- severe hypersensitivity to gadobutrol or fludeoxyglucose F18.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Assessment of Response to Neoadjuvant Chemo-Radio-Therapy (nCRT) for Esophageal and Gastroesophageal Junction Cancer (GEJ) Using a Fully Integrated PET/MRI
Evaluate the potential role of PET/MRI as a predictor of esophageal and junctional cancers in response to neoadjuvant chemoradiotherapy (nCRT).
Read the detailed description
This is a prospective, observational single center study which plans to enroll patients with biopsy proven potentially resectable esophageal or junctional cancer scheduled to receive nCRT (CROSS regimen) prior to surgery.
The study aims to evaluate Routine pre-treatment work-up includes PET to stage the tumour extension.
- PET/MRI (Magnetic resonance imaging) will replace the PET component of CT(computed tomography)
- An additional intermediate 18-FDG (Fluorodeoxyglucose) PET/MRI will be performed during nCRT
- Post nCRT imaging, as required prior to surgery, will be PET/MRI six weeks after treatment completion.
- 8-12 weeks post nCRT completion surgery will be performed, based on each patient's performance status and response to nCRT
- Histopathological samples of the excised tumor and lymph nodes will be used for diagnosis, staging and description of qualitative and quantitative parameters Routine clinical and radiological follow-up for 24 months (for the scope of this study) will follow the standard clinical workflow assigned to this group of patients.
- Conditions
- Esophageal Cancer, Esophageal Neoplasms
- Being tested
- hybrid PET/MRI
- Keywords
- response, neoadjuvant, PET/MRI, radiomics, GEJ 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.
hybrid PET/MRIOther
An additional intermediate 18-FDG PET/MRI will be performed during neoadjuvant chemo-radiation therapy. Routine pre-treatment work-up PET/MRI will replace PET alone.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid PET/MRI | Other | For the purposes of the study, in addition to standard imaging (EUS and CT scan), a fully integrated hybrid PET/MRI (PET/MRI) study with FDG will replace the Standard PET (pre-surgical evaluation) used for evaluating distant metastases and will be considered as the add-on procedure at three time points. The additional evaluation for patients is that during nCRT treatment. Receives: Other: hybrid PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to neoadjuvant treatment -MRI
MRI component including Dynamic Contrast Enhanced (DCE); quantitative evaluation and delta between timepoints
Measured: 0-36 months
Response to neoadjuvant treatment -PET
PET component -quantitative evaluation and delta between timepoints
Measured: 0-36 months
Response to neoadjuvant treatment - Histology
Evaluate degree of tumor regression after neoadjuvant therapy according to the Mandard Tumour regression grade ; integrated Immunohistochemistry
Measured: 0-36 months
Response to neoadjuvant treatment -Radiomics
Radiomic features extracted from hybrid imaging
Measured: 0-36 months
Imaging parameters as potential predictors of tumor response
Select imaging parameters that can be considered potential predictors of the responder/non-responder status assessment
Measured: 0- 48 months
Secondary outcomes (1)
Early regression model (ERI)
Evaluate the ERI model as a predictor of histological response (TRG grade) based on MRI tumor volume assessment
Measured: 0- 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start10 May 2020
- Primary completion10 Feb 2026
- Study completion28 Feb 2026
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.
- More trials run by IRCCS San RaffaeleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro
- Responsible party
- Principal investigator, Francesco De Cobelli, IRCCS San Raffaele
- Investigators
- Francesco De Cobelli, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359732
- Sponsor's protocol ID
- Escape
- Acronym
- Escape
- Status last verified
- Sep 2026
- First submitted
- 20 Apr 2020
- Last updated
- 21 Sep 2026
- 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 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Assessment of Response to Neoadjuvant Chemo-Radio-Therapy (nCRT) for Esophageal and Gastroesophageal Junction Cancer (GEJ) Using a Fully Integrated PET/MRI
- ClinicalTrials.gov ID
- NCT04359732
- Acronym / sponsor ID
- Escape / Escape
- Conditions
- Esophageal Cancer, Esophageal Neoplasms
- Keywords
- response, neoadjuvant, PET/MRI, radiomics, GEJ cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro
- Study start
- 10 May 2020 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 24 Apr 2020 (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.
Evaluate the potential role of PET/MRI as a predictor of esophageal and junctional cancers in response to neoadjuvant chemoradiotherapy (nCRT).
Detailed description
This is a prospective, observational single center study which plans to enroll patients with biopsy proven potentially resectable esophageal or junctional cancer scheduled to receive nCRT (CROSS regimen) prior to surgery.
The study aims to evaluate Routine pre-treatment work-up includes PET to stage the tumour extension.
- PET/MRI (Magnetic resonance imaging) will replace the PET component of CT(computed tomography)
- An additional intermediate 18-FDG (Fluorodeoxyglucose) PET/MRI will be performed during nCRT
- Post nCRT imaging, as required prior to surgery, will be PET/MRI six weeks after treatment completion.
- 8-12 weeks post nCRT completion surgery will be performed, based on each patient's performance status and response to nCRT
- Histopathological samples of the excised tumor and lymph nodes will be used for diagnosis, staging and description of qualitative and quantitative parameters Routine clinical and radiological follow-up for 24 months (for the scope of this study) will follow the standard clinical workflow assigned to this group of patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hybrid PET/MRI | Other | Other: hybrid PET/MRIFor the purposes of the study, in addition to standard imaging (EUS and CT scan), a fully integrated hybrid PET/MRI (PET/MRI) study with FDG will replace the Standard PET (pre-surgical evaluation) used for evaluating distant metastases and will be considered as the add-on procedure at three time points. The additional evaluation for patients is that during nCRT treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- biopsy-proven esophageal or junctional carcinomas (either adenocarcinoma (AC) or squamous cell carcinoma (SCC) for which an Ivor-Lewis transthoracic esophagectomy with supramesocolic and mediastinal lymphadenectomy is indicated;
- visible tumor on pre-treatment imaging;
- ≥ 18 years of age;
- signed informed consent.
Key exclusion criteria (7 listed)
- - incomplete preoperative imaging assessment;
- contraindications to neoadjuvant treatment;
- contraindications to preoperative imaging (such as pacemaker, allergy to contrast agents);
- inability to complete imaging examinations (i.e. severe claustrophobia);
- contraindication to surgery (comorbidities, distant metastatic disease (imaging confirmed));
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 |
|---|---|---|
| hybrid PET/MRIAn additional intermediate 18-FDG PET/MRI will be performed during neoadjuvant chemo-radiation therapy. Routine pre-treatment work-up PET/MRI will replace PET alone. | Other | Hybrid PET/MRI |
Primary outcome
Response to neoadjuvant treatment -MRI
Time frame: 0-36 months
MRI component including Dynamic Contrast Enhanced (DCE); quantitative evaluation and delta between timepoints
Response to neoadjuvant treatment -PET
Time frame: 0-36 months
PET component -quantitative evaluation and delta between timepoints
Response to neoadjuvant treatment - Histology
Time frame: 0-36 months
Evaluate degree of tumor regression after neoadjuvant therapy according to the Mandard Tumour regression grade ; integrated Immunohistochemistry
Response to neoadjuvant treatment -Radiomics
Time frame: 0-36 months
Radiomic features extracted from hybrid imaging
Imaging parameters as potential predictors of tumor response
Time frame: 0- 48 months
Select imaging parameters that can be considered potential predictors of the responder/non-responder status assessment
1 secondary outcome
Early regression model (ERI)
Time frame: 0- 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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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. This study is not recruiting at the moment.
Francesco De Cobelli, MD principal investigator
IRCCS Ospedale San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hybrid PET/MRI in people with Esophageal Cancer and Esophageal Neoplasms, run by IRCCS San Raffaele at 1 site in Italy.
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 7 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: finished, as of the sponsor's last update on 21 Sep 2026. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response to neoadjuvant treatment -MRI (time frame: 0-36 months). The study lists 5 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 21 Sep 2026.