An interventional study of hybrid PET/MRI in Esophageal Cancer and Esophageal Neoplasms, sponsored by IRCCS San Raffaele. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by IRCCS San Raffaele · Not applicable, Interventional, and Diagnostic
Evaluate the potential role of PET/MRI as a predictor of esophageal and junctional cancers in response to neoadjuvant chemoradiotherapy (nCRT).
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.
1,593 studies on the registry are indexed under Esophageal Neoplasms; 461 are open to participants now.
This study's enrollment of 121 is above the median of 58 across 1,171 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Other: hybrid PET/MRI
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.
Response to neoadjuvant treatment -MRI
MRI component including Dynamic Contrast Enhanced (DCE); quantitative evaluation and delta between timepoints
Time frame: 0-36 months
Response to neoadjuvant treatment -PET
PET component -quantitative evaluation and delta between timepoints
Time frame: 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
Time frame: 0-36 months
Response to neoadjuvant treatment -Radiomics
Radiomic features extracted from hybrid imaging
Time frame: 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
Time frame: 0- 48 months
Early regression model (ERI)
Evaluate the ERI model as a predictor of histological response (TRG grade) based on MRI tumor volume assessment
Time frame: 0- 60 months
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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IRCCS San Raffaele