Staging before surgery by combidex MRI in patients with resectable esophageal carcinoma

Preoperative staging by combidex MRI in patients with resectable esophageal carcinoma, a feasibility study - PRECIES trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003133-18-NL

Enrollment

Registered

2016-11-09

Start date

2017-01-19

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Detection of locoregional lymph node metastases in patients with resectable esophageal carcinoma

Interventions

Product Name: ferumoxtran-10 Product Code: ferumoxtran-10 Pharmaceutical Form: Solution for injection INN or Proposed INN: FERUMOXTRAN-10 CAS Number: 189047-99-2 Other descriptive name: FERUMOXTRAN-10

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Patients with recently biopsy proven esophageal cancer, who are planned to undergo a esophagectomy with nCRT • Patients with suspected lymph nodes metastases on EUS or CT before nCRT • Age > 18 years • Providing informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Unable to provide informed consent • Known pregnancy or breastfeeding • Contra-indications for MRI - Epilepsy - Metal implants that are not compatible with MRI • Contra-indications for USPIO based contrast agents - Prior allergic reaction to ferumoxtran-10 or any other iron preparation - Prior allergic reaction contributed to dextran or other polysaccharide, in any preparation - Prior allergic reaction to contrast media of any type - Hereditary hemochromatosis, thalassemia, sickle cell anemia - Known liver or renal insufficiency

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the feasibility and diagnostic accuracy of nano-MRI in the evaluation of locoregional lymph nodes metastases in patients with esophageal cancer whom underwent nCRT and study the effect of nCRT on the detection of locoregional lymph nodes metastases with nano-MRI.;Secondary Objective: -Diagnostic accuracy of the nano-MRI under anesthesia and controlled mechanical ventilation motion in detecting metastases in locoregional lymph nodes in patients with esophageal cancer whom underwent nCRT -Diagnostic accuracy of the nano-MRI in detecting metastases in locoregional lymph nodes ex-vivo after nCRT -Identify the effect of CRT on the detection of lymph nodes metastases with nano-MRI -Identify the quantitative effect of anesthesia and controlled mechanical ventilation motion MRI compared with ‘breathhold’ MRI. -Compare the diagnostic accuracy of nano-MRI with clinical staging results of primary esophageal cancer (CT, PET, EUS) ;Primary end point(s): Diagnostic accuracy of nano-MRI in detecting of locoregional lymph nodes metastases;Timepoint(s) of evaluation of this end point: After nCRT	—

Measure

Time frame

Main Objective: To assess the feasibility and diagnostic accuracy of nano-MRI in the evaluation of locoregional lymph nodes metastases in patients with esophageal cancer whom underwent nCRT and study the effect of nCRT on the detection of locoregional lymph nodes metastases with nano-MRI.;Secondary Objective: -Diagnostic accuracy of the nano-MRI under anesthesia and controlled mechanical ventilation motion in detecting metastases in locoregional lymph nodes in patients with esophageal cancer whom underwent nCRT -Diagnostic accuracy of the nano-MRI in detecting metastases in locoregional lymph nodes ex-vivo after nCRT -Identify the effect of CRT on the detection of lymph nodes metastases with nano-MRI -Identify the quantitative effect of anesthesia and controlled mechanical ventilation motion MRI compared with ‘breathhold’ MRI. -Compare the diagnostic accuracy of nano-MRI with clinical staging results of primary esophageal cancer (CT, PET, EUS) ;Primary end point(s): Diagnostic accuracy of nano-MRI in detecting of locoregional lymph nodes metastases;Timepoint(s) of evaluation of this end point: After nCRT

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Secondary

Measure	Time frame
Secondary end point(s): - Diagnostic accuracy of ex-vivo nano-MRI in detecting locoregional lymph nodes metastases with ‘breathhold’ - Diagnostic accuracy of ex-vivo nano-MRI in detecting locoregional lymph nodes metastases with - Diagnostic accuracy of ex-vivo nano-MRI in detecting locoregional lymph nodes metastases - Effect of locoregional lymph nodes metastases before nCRT ;Timepoint(s) of evaluation of this end point: before and after nCRT	—

Measure

Time frame

Secondary end point(s): - Diagnostic accuracy of ex-vivo nano-MRI in detecting locoregional lymph nodes metastases with ‘breathhold’ - Diagnostic accuracy of ex-vivo nano-MRI in detecting locoregional lymph nodes metastases with - Diagnostic accuracy of ex-vivo nano-MRI in detecting locoregional lymph nodes metastases - Effect of locoregional lymph nodes metastases before nCRT ;Timepoint(s) of evaluation of this end point: before and after nCRT

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Countries

Netherlands

Contacts

Public ContactPRECIES information

Radboudumc

didi.degouw@radboudumc.nl00310243617612

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026