Optimizing Lymph Node Staging in Esophageal Cancer with USPIO-enhanced MRI
Key facts
- Where
- Amsterdam, HollandiaSee the site
- Phase
- 2. fázis
Where in Hollandia
- Amsterdam UMCAmsterdam, HollandiaToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Amsterdam UMC
- Trial code
- EU 2023-506952-26-01
- Record updated
- 2025. július 31.
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; 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); 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); Pregnancy; Non-FDG avid tumor at baseline PET-CT.