2023-506952-26-01Not yet recruitingPhase 2
Optimizing Lymph Node Staging in Esophageal Cancer with USPIO-enhanced MRI
Source: EU CTIS (euclinicaltrials.eu) · Last updated 31 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The primary objectives of this study are: • To determine the feasibility of using USPIO-enhanced MR imaging for initial staging, prior to neoadjuvant chemoradiotherapy. • To determine the diagnostic performance of USPIO-enhanced MR imaging for detecting lymph node metastases at initial staging, compared to (standard) PET-CT. • To determine the feasibility of using USPIO-enhanced MR imaging for restaging, after completion of neoadjuvant therapy. • To determine the diagnostic performance of USPIO-enhanced MR imaging for detecting lymph node metastases at restaging, compared to (standard) PET-CT.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 1 (estimated)
- First submitted
- 22 Apr 2025
- Start date
- 1 Aug 2025
- Lead sponsor
- Amsterdam UMC
- Diseases
- Gastric and esophageal cancer
- EU CT number
- 2023-506952-26-01
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 1
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of any other investigational medicinal product within 30 days prior to receiving study medication until last follow-up visit
- Contra-indications for MR scanning, including patients with a pacemaker, cochlear implant, neurostimulator, non-MR compatible implants, patients with severe claustrophobia or otherwise contra indicated
- Previous treatment for esophageal cancer
Other illness
- English and Dutch language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent
- History of anaphylaxis or hypersensitivity reactions after intravenous administration
- History of iron overload or disturbances in the utilization of iron (e.g., haemochromatosis, hemosiderosis, chronic hemolytic anemia with frequent blood transfusions)
- Active inflammatory diseases
- History of abnormal liver function, or elevated liver enzymes (ALAT or ASAT > 3 times upper limit of normal)
Lab values
- Known hypersensitivity to Ferrotran® (or other USPIO holding agents) or its components dextran or Sodium Citrate
- History of elevated Serum Transferrin Saturation (TSAT) (>50%) or hemoglobin (>10.5mmol/L)
Other
- Pregnancy
- Non-FDG avid tumor at baseline PET-CT
Who the study is looking for
- Histopathological proven cT1-4aN+M0 esophageal adenocarcinoma
- WHO-performance score between 0-2
- Scheduled for neoadjuvant chemoradiotherapy and esophagectomy at baseline
- Aged ≥18 years
- Written informed consent
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC | Amsterdam | Netherlands | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.