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CompletedNCT05855291Updated May 11, 2023

PET/MRI in Predicting the Outcome of Neoadjuvant Chemoradiotherapy With Esophagectomy in Esophageal Cancer Patients

An interventional study of PET/MRI in Esophageal Cancer, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-11.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 5 years 3 months after the study started (first participant enrolled Jan 2018, registered Apr 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Not applicable
Ages
Up to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Esophageal Cancer
03

In context

Esophageal Neoplasms

1,592 studies on the registry are indexed under Esophageal Neoplasms; 460 are open to participants now.

This study's enrollment of 43 is below the median of 58 across 1,170 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Biopsy-proven primary esophageal cancer
  2. Willing to receive therapy
  3. The ability to provide written informed consent and receive the scheduled scans

Exclusion criteria

Exclusion Criteria:

  1. Woman with pregnancy or during lactation
  2. A history of other malignancies or concomitant cancers in different anatomical locations
  3. Not suitable to receive the PET scan such as serum glucose levels of > 200 mg/dL or space phobia
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Integrated PET/MRI

    The study patients receive 18F-FDG PET/MRI before and after neoadjuvant chemoradiotherapy.

    Diagnostic Test: PET/MRI

Interventions

  • Diagnostic testPET/MRI

    The participants receive 18F-FDG PET/MRI before and after neoadjuvant chemoradiotherapy.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 years

07

Study locations

1 site
  • Linkou Chang Gung Memorial Hospital
    Taoyuan, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05855291
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
May 11, 2023
Start date
Jan 22, 2018
Primary completion
Jul 31, 2021
Completion
Jul 31, 2021
Last update
May 11, 2023

Study contacts

Yin-Kai Chao
study director · Chang Gung Memorial Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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