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 study about?

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.

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.

2 initial assessment

An initial assessment is conducted to confirm eligibility and gather baseline health information.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Avcyzo Ujmwdestei Horhzust	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.08.2023

Trial locations

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.

Investigated diseases:

Ovarian cancer

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.

Trial ID:

2023-503398-39-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Improving Ovarian Cancer Diagnosis Using Pyruvic Acid and Gadoteric Acid for Patients Suspected of Having Ovarian Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?