Study of Ferumoxtran-10 Enhanced MRI for Detecting Lymph Node Metastases in Patients with Esophageal Cancer

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What is this study about?

This study focuses on improving the detection of cancer spread in patients with esophageal cancer. The research evaluates a special imaging method that uses Ferrotran, a contrast agent containing tiny iron particles, which is given through intravenous infusion. This substance helps to better visualize lymph nodes during MRI scans.

The purpose of the study is to determine whether using this special contrast-enhanced imaging technique can provide better information about cancer spread to lymph nodes compared to standard imaging methods. This is important both before and after patients receive initial cancer treatment with chemotherapy and radiation therapy.

During the study, participants will receive a single dose of Ferrotran through an infusion into their vein. The amount given depends on the person’s weight. They will then undergo MRI scanning to create detailed images of the lymph nodes. The imaging procedure will be performed twice – once before starting cancer treatment and once after completing it. The total duration of participation in the imaging part of the study is 2 days.

1 Initial imaging examination

You will undergo two types of imaging examinations: a standard PET-CT scan and a special magnetic resonance imaging called USPIO-enhanced MRI

The USPIO-enhanced MRI uses a contrast agent called Ferrotran Lyophilisate that will be given through an intravenous infusion

2 Contrast agent administration

You will receive ferumoxtran-10 (Ferrotran Lyophilisate) through an intravenous infusion

Medical staff will monitor your condition during and after the infusion to check for any reactions to the contrast agent

3 Pre-treatment imaging

The imaging examinations will help determine the presence of cancer in your lymph nodes before starting treatment

These scans will serve as a baseline for comparing changes during your treatment

4 Chemoradiotherapy period

You will receive neoadjuvant chemoradiotherapy (combined chemotherapy and radiation therapy) as part of your standard treatment plan

5 Post-treatment imaging

After completing chemoradiotherapy, you will undergo another round of both imaging examinations (PET-CT and USPIO-enhanced MRI)

These scans will help evaluate how your lymph nodes have responded to the treatment

6 Surgery

Following the imaging examinations, you will undergo an esophagectomy (surgical removal of the affected part of the esophagus) as part of your standard treatment plan

7 Patient feedback

You will be asked to complete a questionnaire about your experience with both types of imaging examinations

The questionnaire will focus on your comfort level during the procedures

Who Can Join the Study?

Must have confirmed esophageal adenocarcinoma (a type of cancer in the food pipe) that has been proven through tissue examination
Must be scheduled to receive both:
- neoadjuvant chemoradiotherapy (combination of chemotherapy and radiation therapy given before surgery)
- esophagectomy (surgery to remove part of the esophagus)
Must have a WHO performance score between 0-2 (a measure of patient’s ability to perform daily activities, where 0 means fully active and 2 means able to do light activities but unable to work)
Must be at least 18 years old
Must be able and willing to provide written informed consent to participate in the study
Both men and women may participate

Who Cannot Join the Study?

Age below 18 years or above 65 years
Inability to undergo MRI scanning (magnetic resonance imaging) due to metal implants, pacemakers, or claustrophobia (fear of confined spaces)
Known allergy or hypersensitivity to USPIO (ultra-small superparamagnetic iron oxide) contrast agents
Pregnant or breastfeeding women
Severe kidney disease or impaired kidney function
Active infections or serious medical conditions that could interfere with study procedures
Previous treatment for esophageal cancer including surgery, chemotherapy, or radiation therapy
Unable to provide informed consent
Participation in other clinical trials within the past 30 days
Medical conditions that would prevent completion of the required imaging procedures

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Ahzpxuloo Uac	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	01.08.2025

Trial locations

Investigated drugs:

FERUMOXTRAN-10

USPIO (Ultrasmall Superparamagnetic Iron Oxide) is a contrast agent used in magnetic resonance imaging (MRI). It is injected into the bloodstream and helps to enhance the visibility of lymph nodes during MRI scans. This makes it easier for doctors to see if cancer has spread to the lymph nodes. The particles are very small and are naturally processed by the body after the imaging is complete.

Chemoradiotherapy is a combination treatment that uses both chemotherapy (drugs that kill cancer cells) and radiotherapy (radiation treatment) to treat cancer. This therapy is given before surgery (neoadjuvant treatment) to help shrink the tumor and treat possible cancer spread.

Esophageal cancer – A disease that develops in the esophagus, the tube connecting the throat to the stomach. The cancer typically begins in the cells lining the inside of the esophagus and can grow through the wall of the esophagus. It usually starts developing in the lower portion of the esophagus, though it can occur anywhere along its length. The disease can cause the esophagus to narrow, making it difficult to swallow food and liquids. As the condition progresses, it may spread to nearby lymph nodes and other organs.

Trial ID:

2023-506952-26-01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Ferumoxtran-10 Enhanced MRI for Detecting Lymph Node Metastases in Patients with Esophageal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?