Clinical trial · Interventional
Assessment of Response to nCRT for GEJ Cancer Using a Fully Integrated PET/MRI
Prediction of Assessment of Response to Neoadjuvant Chemo-Radio-Therapy (nCRT) for Esophageal and Gastroesophageal Junction Cancer (GEJ) Using a Fully Integrated PET/MRI
NCT04359732CI-TRIAL-00102671EscapecompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
Evaluate the potential role of PET/MRI as a predictor of esophageal and junctional cancers in response to neoadjuvant chemoradiotherapy (nCRT).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hybrid PET/MRI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Hybrid PET/MRI
- description
- 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.
- interventionNames
- Other: hybrid PET/MRI
Primary outcomes (5)
- measure
- Response to neoadjuvant treatment -MRI
- timeFrame
- 0-36 months
- description
- MRI component including Dynamic Contrast Enhanced (DCE); quantitative evaluation and delta between timepoints
- measure
- Response to neoadjuvant treatment -PET
- timeFrame
- 0-36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * \- 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.
References
Publications (0)
Data not yet available
No reference posted for this study.