NCT05855291

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 22, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
Last Updated

May 11, 2023

Status Verified

April 1, 2023

Enrollment Period

3.5 years

First QC Date

April 28, 2023

Last Update Submit

May 9, 2023

Conditions

Outcome Measures

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

    3 years

Study Arms (1)

Integrated PET/MRI

EXPERIMENTAL

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

Diagnostic Test: PET/MRI

Interventions

PET/MRIDIAGNOSTIC_TEST

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

Integrated PET/MRI

Eligibility Criteria

AgeUp to 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

Related Publications (1)

  • Chao YK, Chang CB, Chang YC, Chan SC, Chiu CH, Ng SH, Hsieh JC, Wang JH. Baseline and interim [18F]FDG-PET/MRI to assess treatment response and survival in patients with M0 esophageal squamous cell carcinoma treated by curative-intent therapy. Cancer Imaging. 2023 Nov 6;23(1):109. doi: 10.1186/s40644-023-00630-2.

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Study Officials

  • Yin-Kai Chao

    Chang Gung Memorial Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2023

First Posted

May 11, 2023

Study Start

January 22, 2018

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

May 11, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations