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A plain-language summary of the goals, design and what participants do
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.
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
5 criteria
5 criteria
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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 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.
Other trials in this disease – keep exploring while you decide
The Netherlands
Italy
Sweden
FranceFranceFrancesourced from the EU Clinical Trials Register and site verification
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