Assessment of Response to NCRT for GEJ Cancer Using a Fully Integrated PET/MRI
- Conditions
- Esophageal CancerEsophageal Neoplasms
- Interventions
- Other: hybrid PET/MRI
- Registration Number
- NCT04359732
- Lead Sponsor
- IRCCS San Raffaele
- Brief Summary
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 155
- 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.
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- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hybrid PET/MRI hybrid PET/MRI 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.
- Primary Outcome Measures
Name Time Method Response to neoadjuvant treatment -Radiomics 0-36 months Radiomic features extracted from hybrid imaging
Imaging parameters as potential predictors of tumor response 0- 48 months Select imaging parameters that can be considered potential predictors of the responder/non-responder status assessment
Response to neoadjuvant treatment -MRI 0-36 months MRI component including Dynamic Contrast Enhanced (DCE); quantitative evaluation and delta between timepoints
Response to neoadjuvant treatment - Histology 0-36 months Evaluate degree of tumor regression after neoadjuvant therapy according to the Mandard Tumour regression grade ; integrated Immunohistochemistry
Response to neoadjuvant treatment -PET 0-36 months PET component -quantitative evaluation and delta between timepoints
- Secondary Outcome Measures
Name Time Method Early regression model (ERI) 0- 60 months Evaluate the ERI model as a predictor of histological response (TRG grade) based on MRI tumor volume assessment
Trial Locations
- Locations (1)
Deaprtment of Radiology, IRCCS Ospedale San Raffaele
🇮🇹Milano, Italy