Overview
Sponsor-declared trial summary
Esophageal cancer
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) …
Key facts
- Sponsor
- Amsterdam UMC
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05], Diseases [C] - Digestive System Diseases [C06], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Decision date (initial)
- 2025-07-31
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis, Safety, Efficacy
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.
Secondary objectives 3
- Complication/(S)AE rate of USPIO infusion
- Efficiency of study logistics
- Diagnostic performance of the proposed lymph node scoring system for metastatic suspicion on USPIO-enhanced MRI
Conditions and MedDRA coding
Esophageal cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10015362 | Esophageal cancer | 10029104 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-506952-26-00 | Optimizing Lymph Node Staging in Esophageal Cancer with USPIO-enhanced MRI | Amsterdam UMC |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- 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 criteria 12
- English and Dutch language difficulty, dementia or altered mental status prohibiting the understanding and giving of informed consent
- 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
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 5
- Observer’s qualitative assessment of image quality for evaluation of lymph node metastases on USPIO-enhanced MR, compared to PET-CT images
- Time required for observers to assess USPIO-enhanced MRI, compared to standard PET-CT, in minutes
- Patient questionnaire for perceived burden of undergoing USPIO-enhanced MRI, compared to PET-CT
- Accuracy (sensitivity, specificity, positive /negative predictive value, and likelihood ratio) of detecting lymph node metastases on USPIO-enhanced MRI, compared to PET-CT, with pathological assessment as reference standard
- Lymph node size, shape, number, intensity, location, and fibrotic characteristics
Secondary endpoints 3
- Complications, (S)AEs, SUSARs, and toxicity from USPIO-infusion
- Time intervals between all study and standard of care procedures in days
- Accuracy (sensitivity, specificity, positive /negative predictive value, and likelihood ratio) of the proposed lymph node scoring system for metastatic suspicion on USPIO-enhanced MRI
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD7839115 · Product
- Active substance
- FERUMOXTRAN-10
- Other product name
- Ferumoxtran Lyophilisate
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 0.18 millilitre(s)/kilogram
- Max total dose
- 0.18 millilitre(s)/kilogram
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Not Authorised
- ATC code
- V08CB03 — IRON OXIDE, NANOPARTICLES
- MA holder
- SAVING PATIENTS LIVES MEDICAL B.V.
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC
- Sponsor organisation
- Amsterdam UMC
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC
- Contact name
- Dr. S.S. Gisbertz
Public contact point
- Organisation
- Amsterdam UMC
- Contact name
- Dr. S.S. Gisbertz
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 1 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol 2023-506952-26-01 | 1.1 |
| Protocol (for publication) | D4_ Patient Questionnaire | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adult Dutch | 1.3 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis MS 2023-506952-26-01 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-22 | Netherlands | Acceptable 2025-07-25
|
2025-07-31 |