Study on the Use of Iron Oxide Nanoparticles in MRI to Detect Lymph Node Metastasis in Patients with Newly Diagnosed Rectal Cancer

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What is this study about?

This clinical trial focuses on studying rectal cancer and its spread to nearby lymph nodes, known as mesorectal lymph node metastases. The study will use a special type of Magnetic Resonance Imaging (MRI) that involves a contrast agent called Ferumoxtran-10, which contains tiny particles of iron oxide. This contrast agent helps to create clearer images of the lymph nodes during the MRI scan.

The purpose of the study is to determine how accurately this enhanced MRI can identify the stage of cancer in the lymph nodes compared to the traditional method of examining tissue samples after surgery. Participants in the study will undergo an MRI scan with the Ferumoxtran-10 contrast agent, as well as a standard MRI without the contrast. These imaging results will be compared to the findings from the tissue samples taken during surgery.

The study will involve patients who have been newly diagnosed with rectal cancer and are scheduled for surgery or a short course of radiotherapy before surgery. The trial aims to improve the understanding of how well the enhanced MRI can detect cancer spread to the lymph nodes, which could potentially lead to better treatment planning for patients in the future.

1 joining the study

Upon joining the study, informed consent is required. This involves understanding the study’s purpose and agreeing to participate.

Eligibility criteria include being over 18 years of age, having newly diagnosed rectal cancer, and being scheduled for direct surgery or short course radiotherapy.

2 initial assessment

An initial assessment is conducted to evaluate the current stage of rectal cancer using standard imaging techniques.

3 administration of contrast agent

The contrast agent Ferumoxtran-10, which contains iron oxide nanoparticles, is administered through an intravenous bolus injection or IV infusion.

This step is crucial for enhancing the quality of the MRI scans.

4 MRI scan

An MRI scan is performed to assess the pelvic lymph nodes for metastasis. This scan uses the Ferumoxtran-10 contrast to improve accuracy.

The goal is to determine the clinical nodal stage (cN-stage) of the cancer.

5 comparison with histopathology

The results from the MRI scan are compared with histopathological findings obtained after surgery.

This comparison helps in assessing the accuracy of the MRI in determining the nodal stage.

6 follow-up

Regular follow-up appointments are scheduled to monitor the patient’s health and any changes in the condition.

These follow-ups are important for evaluating the long-term outcomes of the treatment and imaging techniques used.

Who Can Join the Study?

Provide your agreement to participate by signing a form that explains the study and your rights, known as an informed consent.
Be a male or female who is at least 18 years old.
Have been recently diagnosed with rectal cancer and are scheduled for surgery or a short course of radiation therapy, known as SCRT.
If you are a female, you must either be unable to have children, which means you have not had a menstrual period for at least one year or have had surgery to prevent pregnancy.
If you are a woman who can have children, you must take steps to prevent pregnancy during the study and for at least three months after the study ends.

Who Cannot Join the Study?

Patients who do not have rectal cancer cannot participate. Rectal cancer is a type of cancer that affects the last part of the large intestine.
Patients who do not have mesorectal lymph node metastases cannot participate. This means the cancer has not spread to the lymph nodes near the rectum.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Both male and female patients are eligible, so gender is not a reason for exclusion.
Patients who are considered part of a vulnerable population are not excluded based on this criterion.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Vbfmjgupfgtgdyas hydjpenxrlyligv	Turku	Finland

Trial status

Country	Status	Recruitment Start
Finland	Recruiting	01.08.2024

Trial locations

Ferumoxtran-10 is a medication used in this clinical trial to enhance Magnetic Resonance Imaging (MRI) scans. It helps doctors get a clearer picture of the lymph nodes in patients with newly diagnosed rectal cancer. This enhanced imaging is compared to standard imaging techniques to see if it provides more accurate information about the cancer’s stage.

Investigated diseases:

Rectal cancer – Rectal cancer is a type of cancer that begins in the rectum, which is the last several inches of the large intestine before the anus. It typically starts as a growth on the inner lining of the rectum, known as a polyp, which can become cancerous over time. As the disease progresses, the cancer cells can invade deeper layers of the rectal wall and potentially spread to nearby lymph nodes and other organs. Symptoms may include changes in bowel habits, rectal bleeding, and abdominal discomfort. The progression of rectal cancer can vary, with some cases remaining localized while others may spread to distant parts of the body.

Mesorectal lymph node metastases – Mesorectal lymph node metastases occur when cancer cells spread from the primary tumor in the rectum to the lymph nodes located in the mesorectum, the fatty tissue surrounding the rectum. This spread is a common pathway for rectal cancer to advance, indicating that the cancer is moving beyond its original site. The presence of cancer in these lymph nodes can affect the staging of rectal cancer and may influence the course of the disease. As the metastases develop, they can lead to further dissemination of cancer cells to other parts of the body. The progression of mesorectal lymph node metastases is a critical factor in understanding the overall advancement of rectal cancer.

Trial ID:

2024-514831-34-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Use of Iron Oxide Nanoparticles in MRI to Detect Lymph Node Metastasis in Patients with Newly Diagnosed Rectal Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?