FDG-PET/MRI for re-staging of esophageal cancer: a feasibility study

FDG-PET/MRI for re-staging of esophageal cancer: a feasibility study - PET/MRI in esophageal cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50029

Enrollment

Registered

2020-12-21

Start date

2021-03-01

Completion date

Unknown

Last updated

2026-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

carcinoma of the oesophagus oesophageal cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age *18 years; - Histologically proven esophageal adenocarcinoma or squamous cell carcinoma located caudally to the carina; - Completed neoadjuvant chemoradiotherapy (nCRT); - Scheduled to undergo FDG-PET/CT at 4-6 weeks after nCRT or at 8-12 weeks after nCRT as part of standard clinical care.

Exclusion criteria

Exclusion criteria: - Contra-indications for MRI (e.g. pacemaker, metal implant, claustrophobia); - Contra-indications for iodinated contrast media (e.g. previous contrast-allergy or eGFR

Design outcomes

Primary

Measure	Time frame
The primary study parameter is qualitative re-staging after nCRT based on FDG-PET/MRI versus FDG-PET/CT, with pathology as gold standard (i.e. histopathologic assessment of the resection specimen when patients undergo surgery after nCRT, or histopathology/cytopathology of the primary tumor and suspected (distant) metastases as obtained during standard follow-up when patients do not undergo surgery or postpone surgery after nCRT).The other primary study parameters to assess feasibility include: experienced burden of undergoing FDG-PET/MRI, measurements of the primary tumor and lymph nodes, quantitative measurements of standardized uptake values at the primary tumor and suspected locoregional lymph nodes on FDG-PET/MRI compared to FDG-PET/CT, and quantitative measurements of the apparent diffusion coefficient at the primary tumor and suspected locoregional lymph nodes on FDG-PET/MRI.	—

Measure

Time frame

The primary study parameter is qualitative re-staging after nCRT based on FDG-PET/MRI versus FDG-PET/CT, with pathology as gold standard (i.e. histopathologic assessment of the resection specimen when patients undergo surgery after nCRT, or histopathology/cytopathology of the primary tumor and suspected (distant) metastases as obtained during standard follow-up when patients do not undergo surgery or postpone surgery after nCRT).The other primary study parameters to assess feasibility include: experienced burden of undergoing FDG-PET/MRI, measurements of the primary tumor and lymph nodes, quantitative measurements of standardized uptake values at the primary tumor and suspected locoregional lymph nodes on FDG-PET/MRI compared to FDG-PET/CT, and quantitative measurements of the apparent diffusion coefficient at the primary tumor and suspected locoregional lymph nodes on FDG-PET/MRI.

—

Secondary

Measure	Time frame
Not applicable, since the study has one primary objective.	—

Countries

Netherlands

Outcome results