PET/MRI in Predicting the Outcome of Neoadjuvant Chemoradiotherapy With Esophagectomy in Esophageal Cancer Patients
Primary Purpose
Esophageal Cancer
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
PET/MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Esophageal Cancer
Eligibility Criteria
Inclusion Criteria: Biopsy-proven primary esophageal cancer Willing to receive therapy The ability to provide written informed consent and receive the scheduled scans Exclusion Criteria: Woman with pregnancy or during lactation A history of other malignancies or concomitant cancers in different anatomical locations Not suitable to receive the PET scan such as serum glucose levels of > 200 mg/dL or space phobia
Sites / Locations
- Linkou Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Integrated PET/MRI
Arm Description
The study patients receive 18F-FDG PET/MRI before and after neoadjuvant chemoradiotherapy.
Outcomes
Primary Outcome Measures
Overall survival
Being calculated from the date of diagnosis to the date of death or censor at the date of the last follow- up for surviving patients
Secondary Outcome Measures
Full Information
NCT ID
NCT05855291
First Posted
April 28, 2023
Last Updated
May 9, 2023
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05855291
Brief Title
PET/MRI in Predicting the Outcome of Neoadjuvant Chemoradiotherapy With Esophagectomy in Esophageal Cancer Patients
Official Title
Investigating the Role of Integrated 18FDG-PET/MRI in Predicting the Treatment Outcome of Neoadjuvant Concurrent Chemoradiotherapy Followed by Esophagectomy for Patients With Esophageal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Integrated PET/MRI has the advantage to assess the metabolism, diffusion, and perfusion parameters of the tumor simultaneously. Recently, PET/MRI has been investigated in several cancers with promising results. In this study, we prospectively investigate the role of multiparametric PET/MRI in evaluating the outcome of patients with esophageal cancer treated by neoadjuvant chemoradiotherapy and surgery.
Detailed Description
Background:
Esophageal carcinoma is ranked as the 6th leading cancer in Taiwan. In recent years, the survival of patients with esophageal cancer has been improved by the use of neoadjuvant chemoradiotherapy with esophagectomy. But it is reported that only patients who were responsive to neoadjuvant therapy would have prolonged survival. And accurate clinical or imaging modality parameters for prognostic prediction are still lacking.
Traditionally, clinicians rely on endoscopic ultrasound (EUS) and computed tomography (CT) to evaluate the treatment response of esophageal cancer patients. After the neoadjuvant chemotherapy, the accuracy of EUS for assessment of primary tumor or regional nodal sites is reported to be 45-82% or 55-94%, respectively. As for CT, the reported sensitivity is also suboptimal, ranging from 33 to 55%. The specificity is 50-71%. In this regard, 18F-FDG PET/CT has higher sensitivity and specificity of 57-86% and 46-93% than other imaging modalities. But it is still difficult to precisely assess the treatment response depending on these imaging studies.
Functional MRI has been proven to be useful to evaluate treatment responses in various cancers. However, the application of functional MRI in esophageal cancer is limited. One investigator has reported that the apparent diffusion coefficient (ADC) value derived from diffusion MRI (DWI) had the potential to predict the response of esophageal cancer patients. After chemotherapy, the velocity of contrast across the vascular wall was also reported to change substantially in the dynamic contrast MRI (DCE MRI) study.
Integrated PET/MRI has the advantage to perform multiparametric imaging and to assess tumor metabolism (SUV, TLG), ADC, and DCE MRI parameters simultaneously. Recently, PET/MRI has been investigated in several cancers with promising results. In this study, the investigators prospectively explore the role of multiparametric PET/MRI imaging in evaluating the outcome of patients with esophageal cancer.
Material and method:
The study patients receive 18F-FDG PET/MRI before and after neoadjuvant chemoradiotherapy. And the functional imaging parameters on PET/MRI are calculated and correlated with the treatment outcome.
Material and method:
The study patients receive 18F-FDG PET/MRI before and during definitive chemoradiotherapy. And the corresponding functional imaging parameters are calculated and correlated with the treatment outcome.
18F-FDG PET/MRI: PET/MRI is performed on a Biograph mMR (Siemens Healthcare, Erlangen, Germany). The PET/MRI system is equipped with 3-T magnetic field strength, total imaging matrix coil technology covering the entire body with multiple integrated radiofrequency surface coils, and a fully functional PET system with avalanche photodiode technology embedded in the magnetic resonance gantry.
Statistical analysis: Overall survival (OS) serves as the main outcome measure. OS is calculated from the date of diagnosis to the date of death or censored at the date of the last follow-up for surviving patients. The cutoff values for the clinical variables and imaging parameters in survival analysis are determined using the log-rank test. Survival curves are plotted using the Kaplan-Meier method. The effect of each individual variable is initially evaluated using univariate analysis. Cox regression models are used to identify the predictors of survival. Two-tailed P values < 0.05 are considered statistically significant.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Integrated PET/MRI
Arm Type
Experimental
Arm Description
The study patients receive 18F-FDG PET/MRI before and after neoadjuvant chemoradiotherapy.
Intervention Type
Diagnostic Test
Intervention Name(s)
PET/MRI
Intervention Description
The participants receive 18F-FDG PET/MRI before and after neoadjuvant chemoradiotherapy.
Primary Outcome Measure Information:
Title
Overall survival
Description
Being calculated from the date of diagnosis to the date of death or censor at the date of the last follow- up for surviving patients
Time Frame
3 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Biopsy-proven primary esophageal cancer
Willing to receive therapy
The ability to provide written informed consent and receive the scheduled scans
Exclusion Criteria:
Woman with pregnancy or during lactation
A history of other malignancies or concomitant cancers in different anatomical locations
Not suitable to receive the PET scan such as serum glucose levels of > 200 mg/dL or space phobia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yin-Kai Chao
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Linkou Chang Gung Memorial Hospital
City
Taoyuan
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
PET/MRI in Predicting the Outcome of Neoadjuvant Chemoradiotherapy With Esophagectomy in Esophageal Cancer Patients
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