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Study on the Use of Hyperpolarized Pyruvate for MRI Scans in Patients with Pancreatic Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Pancreatic Cancer, a type of cancer that begins in the tissues of the pancreas. The study involves the use of a special treatment called Hyperpolarized [1-13C]pyruvate, which is administered as an injection. This treatment acts as a contrast agent to help improve imaging techniques.

The purpose of the study is to optimize a scanning technique known as MR-hyperpolarisation in patients with pancreatic cancer. This technique uses the hyperpolarized pyruvate to enhance the quality of images obtained from the pancreas and other related areas, such as the liver. The study aims to gather baseline data on how this technique works in different parts of the body, including both cancerous and non-cancerous tissues. Additionally, the study will confirm the safety and feasibility of using hyperpolarized pyruvate in these patients.

Participants in the study will receive the hyperpolarized pyruvate injection, and then undergo MR-hyperpolarisation scanning. The study will explore how the signals from this scanning technique relate to the patients' response to chemotherapy, which will be further tested in future studies. The trial will help researchers understand the potential of this imaging method in improving the diagnosis and treatment of pancreatic cancer.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and previous treatments. This includes having a verified diagnosis of pancreatic cancer and being scheduled for or having received chemotherapy.
Step 2
Initial assessment
An initial assessment is conducted to evaluate overall health and organ function. This involves blood tests to check parameters like blood cell counts and liver function.
Step 3
Preparation for scanning
Preparation for the MR-hyperpolarisation scan involves ensuring that the patient is ready for the procedure. This includes confirming that the patient is not pregnant and is using effective contraception if applicable.
Step 4
Administration of medication
The medication used in the study is Hyperpolarized [1-13C]pyruvate, administered as an injection through an intravenous route. The dosage and frequency are determined based on previous studies to ensure safety.
Step 5
MR-hyperpolarisation scanning
During the scan, the focus is on obtaining images and data from the pancreas and liver. The scan measures specific parameters to compare tumor and non-tumor tissues.
Step 6
Post-scan evaluation
After the scan, results are evaluated to assess the safety and effectiveness of the procedure. This includes analyzing the data collected during the scan.
Step 7
Follow-up
Follow-up appointments are scheduled to monitor health and any potential side effects. The study aims to gather data over time to explore correlations with chemotherapy responses.

Who can join the trial?

13 criteria

Patients must have **pancreatic cancer** that cannot be removed by surgery, or has come back after treatment. This must be confirmed by examining tissue samples.
Patients should be scheduled to start their first round of **palliative chemotherapy** (treatment to relieve symptoms) or have already completed at least 4 cycles of chemotherapy.
Patients must be at least 18 years old.
Patients should have a **WHO performance status** of 0 to 2, which means they are fully active or have some limitations but can still take care of themselves.
Patients need to have adequate blood and organ function, which includes:
- **ANC** (a type of white blood cell count) of at least 1,500 per microliter.
- **Platelet count** greater than 100 per microliter.
- **Se bilirubin** less than 1.5 times the upper normal limit.
- **ASAT, ALAT, and AP** (liver enzymes) up to 2.5 times the upper normal limit, or up to 5 times if there are liver metastases.
- **Se creatinine** up to 1.5 times the upper normal limit or a creatinine clearance of at least 30 ml/min.
- **INR and aPTT** (blood clotting tests) at most 1.5 times the upper normal limit, except for patients on blood-thinning treatment.
- Women who are not postmenopausal or surgically sterile must have a negative pregnancy test and use effective birth control during the study. This can include hormonal methods or an intrauterine device. If the partner is infertile or there are no sexual activities, this is also acceptable.
- Patients must speak Danish.
- Patients must be able and willing to follow the study requirements after giving informed consent.

Who cannot join the trial?

5 criteria

Patients who are not diagnosed with pancreatic cancer cannot participate.
Individuals who are not within the specified age range for the study are excluded. The age range is typically defined by the study but is not specified here.
Participants who are part of a vulnerable population, which means they might have additional health or social challenges, are not eligible.
Patients who have not been deemed safe for the use of the study's specific scanning technique or infusion process are excluded.
Individuals who do not meet other specific health criteria set by the study, which are not detailed here, cannot participate.

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Aarhus University Hospital
Aarhus, Denmark

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Investigated drugs

13C-Pyruvate is a special form of pyruvate used in this study to improve MRI scans. It is designed to help doctors see the pancreas and other organs more clearly in patients with pancreatic cancer. The study aims to ensure that using 13C-Pyruvate is safe and effective for this purpose.

Pyruvic Acid

What is already known about the treatment

Pyruvate (13C) – This medication is administered through infusion and is currently being studied in clinical trials for its use in pancreatic cancer. It is not yet widely used in standard medical practice but is being explored for its potential benefits in imaging and treatment response assessment. The main therapeutic indication is pancreatic cancer, where it is used to enhance MR-hyperpolarisation scanning techniques. At the molecular level, Pyruvate (13C) works by enhancing magnetic resonance signals, allowing for better visualization of cancerous tissues. It falls under the pharmacological classification of diagnostic agents, specifically used in imaging studies.

Investigated diseases

Pancreatic Cancer – Pancreatic cancer is a disease where malignant cells form in the tissues of the pancreas, an organ located behind the stomach that helps with digestion and blood sugar regulation. It often begins in the cells that produce digestive juices or hormones. As the cancer progresses, it can invade nearby organs and spread to other parts of the body. Symptoms may not appear until the disease is advanced, and they can include jaundice, weight loss, and abdominal pain. The progression of pancreatic cancer can vary, with some tumors growing slowly and others more rapidly. The disease is often diagnosed at a later stage due to its subtle early symptoms.