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Pet ReInforced by MRI Enhancing detection of Residual Oesophageal cancer

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28571
Enrollment
20
Registered
2021-03-19
Start date
2021-07-13
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Locally advanced esophageal adenocarcinoma or squamous cell carcinoma

Interventions

Patients receive treatment according to standard clinical care during the conduct of the study. Patients who participate in this study will undergo one FDG-PET/MRI scan in total, planned sequentially

Sponsors

Erasmus MC
Lead Sponsor

Eligibility

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.

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 <30 ml/min/1,73m2); - FDG-non avid tumor as determined from the pre-treatment PET/CT scan; - Incapacitated patients, prohibiting the understanding and giving of informed consent and to complete the questionnaire on experienced burden with PET/MRI.

Design outcomes

Primary

MeasureTime 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).

Secondary

MeasureTime frame
Experienced burden of undergoing FDG-PET/MRI; quantitative measurements of the primary tumor and lymph nodes.

Contacts

Public ContactMaartje Valkema

Erasmus MC

m.valkema@erasmusmc.nl010 704 1223

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)