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Study on Improving Ovarian Cancer Diagnosis Using Pyruvic Acid and Gadoteric Acid for Patients Suspected of Having Ovarian 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 focuses on improving the diagnosis and treatment planning for ovarian cancer. The study will use advanced imaging techniques, including MRI (Magnetic Resonance Imaging), to better understand the disease. Two specific substances will be used in this study: Hyperpolarized [1-13C]pyruvate and Dotarem, which are both injected into the body to enhance the quality of the MRI images. These substances help in visualizing the cancer more clearly, which can aid in making more accurate diagnoses.

The purpose of the study is to develop a model that can identify ovarian cancer more accurately and determine the severity of the disease. This involves analyzing blood samples and using functional and metabolic MRI techniques. The study aims to improve the accuracy of diagnosing ovarian cancer and to help doctors decide on the best treatment approach. Participants will undergo MRI scans and provide blood samples, which will be analyzed to see if these methods can distinguish between patients with and without cancer.

The study will also assess whether the use of Hyperpolarized [1-13C]pyruvate in MRI contributes to a more accurate diagnosis and staging of ovarian cancer. Additionally, the study will evaluate the repeatability and reliability of these imaging techniques in patients suspected of having ovarian cancer. The ultimate goal is to enhance the tools available for diagnosing and planning the treatment of ovarian cancer, potentially leading to better outcomes for patients.

The research process

The trial runs in 8 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, participation is confirmed for individuals aged 18 to 85 who are suspected of having epithelial ovarian cancer and can understand Danish.
Step 2
Initial assessment
An initial assessment is conducted to confirm eligibility and gather baseline health information.
Step 3
Blood sample collection
Blood samples are collected to analyze nuclear magnetic resonance (NMR)-derived metabolomics. This analysis helps in distinguishing patients with cancer from those without cancer and predicting the correct diagnosis.
Step 4
MRI procedures
Functional and metabolic magnetic resonance imaging (MRI) techniques are used. This includes dynamic contrast-enhanced MRI (DCE MRI), diffusion kurtosis imaging (DKI), and 31P magnetic resonance spectroscopy (MRS) to evaluate diagnostic performance and assist in staging ovarian cancer.
Step 5
Administration of hyperpolarized [1-13C]pyruvate
The medication Hyperpolarized [1-13C]pyruvate is administered through an intravenous injection. This helps in assessing the contribution to correct histopathological diagnosis and staging of ovarian cancer.
Step 6
Administration of gadoteric acid
The medication Dotarem, which contains gadoteric acid, is administered as a solution for injection intravenously. This is part of the imaging process to enhance MRI results.
Step 7
Data analysis and follow-up
Data from the imaging and blood tests are analyzed to create a diagnostic algorithm. This algorithm aims to improve the accuracy of diagnosis and staging of ovarian cancer.
Step 8
Completion of study participation
Participation in the study is completed by the estimated end date of August 1, 2028. Results from the study contribute to the development of improved diagnostic methods for ovarian cancer.

Who can join the trial?

5 criteria

The patient must have a suspected case of epithelial ovarian cancer. This means the doctors think there might be cancer in the ovaries, which are part of the female reproductive system.
The patient should be referred to the Department of Gynaecology and Obstetrics at a specific hospital and selected for a multidisciplinary team (MDT). This is a group of healthcare professionals who work together to plan the best treatment.
The patient must understand the Danish language. This is important for communication and understanding the study details.
The patient should be between the ages of 18 and 85 years. This means they must be at least 18 years old but not older than 85.
The study is only for female patients. This means only women can participate.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with ovarian cancer cannot participate. Ovarian cancer is a type of cancer that starts in the ovaries, which are part of the female reproductive system.
Only female patients are eligible, so male patients cannot participate.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study, but it is not specified here.
Patients who belong to a vulnerable population, such as those who may not be able to give informed consent, are not eligible.

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Aarhus University Hospital
Aarhus, Denmark

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Investigated drugs

Nuclear Magnetic Resonance (NMR)-Derived Metabolomics
is a technique used in this trial to analyze blood samples. It helps in identifying specific patterns of metabolites, which are small molecules in the blood. This information can be used to improve the diagnosis of ovarian cancer by detecting unique metabolic changes associated with the disease.
Functional and Metabolic MRI Techniques
are advanced imaging methods used in this trial to provide detailed pictures of the body's internal structures. These techniques help in assessing the function and metabolism of tissues, which can aid in identifying ovarian cancer and determining the severity of the disease.

What is already known about the treatment

Carboplatin – Carboplatin is typically administered intravenously, meaning it is given through a vein. It is a well-established medication in the treatment of ovarian cancer, widely recognized in medical literature. The main therapeutic use of Carboplatin is to treat ovarian cancer by interfering with the DNA of cancer cells, preventing them from dividing and growing. It belongs to the pharmacological class of platinum-based chemotherapy drugs, which are known for their ability to damage the DNA of cancer cells, leading to cell death.

Investigated diseases

Ovarian Cancer – Ovarian cancer is a type of cancer that begins in the ovaries, which are the female reproductive glands where eggs are produced. It often goes undetected until it has spread within the pelvis and abdomen, making it more challenging to treat. The disease can start in different types of cells within the ovaries, leading to various forms of ovarian cancer. Symptoms may include bloating, pelvic pain, and changes in bowel habits, but they are often subtle and easily mistaken for other conditions. As the cancer progresses, it can spread to nearby tissues and organs, complicating the condition further. Early detection is crucial for managing the disease effectively.