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Optimizing Lymph Node Staging in Esophageal Cancer with USPIO-enhanced MRI
EU CTIS ID: 2023-506952-26-01
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- English and Dutch language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent
- Use of any other investigational medicinal product within 30 days prior to receiving study medication until last follow-up visit
- Pregnancy
- Non-FDG avid tumor at baseline PET-CT
- 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
- Known hypersensitivity to Ferrotran® (or other USPIO holding agents) or its components dextran or Sodium Citrate
See the full eligibility criteria
- 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
- English and Dutch language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent
- Use of any other investigational medicinal product within 30 days prior to receiving study medication until last follow-up visit
- Pregnancy
- Non-FDG avid tumor at baseline PET-CT
- 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
- Known hypersensitivity to Ferrotran® (or other USPIO holding agents) or its components dextran or Sodium Citrate
- 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)
- History of elevated Serum Transferrin Saturation (TSAT) (>50%) or hemoglobin (>10.5mmol/L)
- Previous treatment for esophageal cancer
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.