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Study on the Safety and Dosage of Ferumoxtran-10 for Examining Lymph Nodes in Rectal Cancer Patients Using NanoEcho Imaging Device

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What is this study about?

This clinical trial is focused on studying rectal cancer, a type of cancer that affects the last part of the large intestine. The study will use a treatment called NEP-1, which is a solution for injection containing ferumoxtran-10. This substance is also known by other names, such as BMS-180549 and AMI-227. The purpose of the study is to evaluate the dose and safety of NEP-1 when used with a special imaging device called the NanoEcho Imaging Device. This device helps visualize the movement of tiny particles in the body to check if the cancer has spread to nearby lymph nodes.

The study is divided into two parts. In the first part, healthy volunteers will receive the NEP-1 injection to determine the right dose and timing for examining lymph nodes using the NanoEcho Imaging Device. In the second part, patients with rectal cancer will receive the same treatment to confirm the findings from the first part. The study aims to see how well the device can detect changes in the lymph nodes and to ensure the treatment is safe for patients.

Participants in the study will receive the NEP-1 injection and undergo imaging with the NanoEcho Imaging Device. The study will monitor the size and distance of lymph nodes from the injection site and check for any side effects or changes in health. The goal is to improve the understanding of how rectal cancer spreads and to develop better ways to detect it early. The study is expected to continue until mid-2025.

1 joining the trial

Upon joining the trial, participants will be required to provide written informed consent. This is a document that confirms understanding of the trial and agreement to participate.

Participants will be divided into two groups: Part A for healthy volunteers and Part B for rectal cancer patients.

2 initial assessment

Participants will undergo an initial assessment to ensure they meet the eligibility criteria. This includes a review of medical history, physical examination, and laboratory tests.

For Part B participants, an MRI scan must have been performed within the last 3 months before the trial.

3 administration of NEP-1

Participants will receive an injection of NEP-1, which is a solution containing the active substance ferumoxtran-10. This is administered through submucosal use, meaning it is injected under the mucous membrane.

The dosage and timing of the injection will be determined based on the trial’s objectives.

4 imaging examination

After the administration of NEP-1, participants will undergo imaging examinations using the NanoEcho Imaging Device. This device is used to examine the rectal lymph nodes.

The purpose of this examination is to evaluate the dose and safety of NEP-1 and to assess the imaging results.

5 monitoring and follow-up

Participants will be monitored for any adverse events, which are any unwanted effects that may occur during the trial.

Regular follow-up visits will be scheduled to assess the participant’s health and to gather data on the trial’s outcomes.

6 completion of the trial

Upon completion of the trial, participants will have a final assessment to ensure their well-being.

Participants will be informed about the results of the trial and any further steps if necessary.

Who Can Join the Study?

  • Part A: You must be willing and able to give written informed consent to participate in the trial.
  • Part A: You should be a healthy male or a female who cannot have children, aged between 18 and 50 years.
  • Part A: Your body mass index (BMI) should be between 18.5 and 30.0 kg/m2. BMI is a measure of body fat based on height and weight.
  • Part A: You should be medically healthy without any significant medical history or abnormal findings during the screening visit.
  • Part A: If you are a woman who cannot have children, you must have had certain surgeries like hysterectomy (removal of the uterus), bilateral salpingectomy (removal of both fallopian tubes), or bilateral oophorectomy (removal of both ovaries), or be post-menopausal, which means you haven’t had a period for 12 months. In some cases, a blood test may be needed to confirm this.
  • Part A: Male participants must agree to use a condom, be vasectomized (a procedure to prevent sperm from being part of the semen), or practice sexual abstinence to prevent pregnancy and drug exposure to a partner. You should also refrain from donating sperm until 3 months after the trial medication is given.
  • Part A: If you are a male participant with a female partner who can have children, she must use effective birth control methods to prevent pregnancy from at least 2 weeks before to 4 weeks after the trial medication is given.
  • Part B: You must be willing and able to give written informed consent to participate in the trial.
  • Part B: You should be a male or a female who cannot have children, aged 18 years or older.
  • Part B: If you are a woman who cannot have children, you must have had certain surgeries like hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, or be post-menopausal, which means you haven’t had a period for 12 months. In some cases, a blood test may be needed to confirm this.
  • Part B: Male participants must agree to use a condom, be vasectomized, or practice sexual abstinence to prevent pregnancy and drug exposure to a partner. You should also refrain from donating sperm until 3 months after the trial medication is given.
  • Part B: If you are a male participant with a female partner who can have children, she must use effective birth control methods to prevent pregnancy from at least 2 weeks before to 4 weeks after the trial medication is given.
  • Part B: You must have primary rectal cancer that is planned for surgery, with suspected spread to lymph nodes but no suspicion of cancer spreading to other parts of the body. An MRI scan must have been done within the last 3 months before the trial medication is given.
  • Part B: You must be diagnosed with clinical stage T1-T4 rectal cancer. This refers to the size and extent of the main tumor.
  • Part B: It should be possible to use a probe in the rectum, meaning there should be no tumor blocking the way.

Who Cannot Join the Study?

  • Patients who are not within the specified age range cannot participate.
  • Patients who are not diagnosed with rectal cancer cannot participate in Part B of the study.
  • Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
  • Patients who are not healthy volunteers cannot participate in Part A of the study.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Region Skane Skanes Universitetssjukhus Lund Sweden
CTC Clinical Trial Consultants AB Uppsala Sweden

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Recruiting
01.09.2024

Trial locations

Investigated drugs:

NEP-1 (Ferumoxtran) is a special type of particle used in medical imaging. In this trial, it helps doctors see the lymph nodes in the rectal area more clearly. This is important because it can help in understanding the condition of these lymph nodes, especially in patients with rectal cancer. The trial aims to find the right amount of NEP-1 to use and the best time to take images after it is given. This can help in diagnosing and planning treatment for rectal cancer more effectively.

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 closest to 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 cancer progresses, it can invade deeper layers of the rectal wall and spread to nearby lymph nodes and other organs. The disease may cause symptoms such as changes in bowel habits, rectal bleeding, and abdominal discomfort. Over time, rectal cancer can lead to complications such as bowel obstruction or perforation. The progression of the disease can vary depending on factors like the size and location of the tumor and whether it has spread to other parts of the body.

Trial ID:
2024-515335-29-00
Protocol code:
NEIS001
Trial Phase:
Therapeutic exploratory (Phase II)

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