Study of Combined Imaging with Hyperpolarized [1-13C]Pyruvate and Fludeoxyglucose (18F) for Cancer Detection in Patients with Breast Cancer, Neuroendocrine Tumors, Lymphomas, or Sarcomas

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What is this study about?

This study focuses on testing a new imaging method in patients with various types of cancer, including breast cancer, neuroendocrine neoplasms, lymphomas, and sarcomas. The research combines two different imaging techniques: Magnetic Resonance Spectroscopy using a substance called hyperpolarized [1-13C]pyruvate and PET scanning using Fluor-18-FDG (a radioactive form of glucose).

The purpose of this study is to determine whether it is possible to perform both imaging methods at the same time to better understand how tumors use energy. During the study, participants will receive two different injectable substances: hyperpolarized [1-13C]pyruvate and Fluor-18-FDG. Both substances will be given through an intravenous injection, and then special images will be taken using a combined PET/MR scanner.

This research will help doctors better understand how tumors process different nutrients and may lead to improved ways of detecting and monitoring cancer. The imaging procedure will be performed once for each participant, and the total dose of each substance has been carefully calculated to ensure safety.

1 Initial imaging procedure preparation

You will undergo a combined imaging procedure using two different methods: PET scan (which shows how your body uses sugar) and MR spectroscopy (which shows how your body processes certain substances).

The procedure will take place in a special combined PET/MR scanner, which allows both scans to be performed at the same time.

2 First injection

You will receive an injection of Fluor-18-FDG (a special form of sugar that can be seen on PET scans) through an intravenous line.

The dose will be between 400 MBq and 210 GBq, determined by your medical team based on specific requirements.

3 Second injection

You will receive a second injection of hyperpolarized pyruvate through an intravenous line.

This substance helps show how your body’s cells process energy.

4 Imaging procedure

You will lie still in the PET/MR scanner while both scans are performed simultaneously.

The machine will take images showing how your body processes both injected substances.

The focus will be on measuring tumor activity and how it uses both the sugar and pyruvate substances.

5 Completion

After the scanning is complete, the medical team will remove the intravenous line.

This completes your participation in the imaging procedure.

Who Can Join the Study?

Age: Must be an adult (18 years or older)
Gender: Both men and women can participate
Must have a confirmed diagnosis of one of these cancers:
- Breast cancer
- Neuroendocrine neoplasm (tumors that begin in specialized cells that produce hormones)
- Lymphoma (cancer that begins in infection-fighting cells of the immune system)
- Sarcoma (cancer that starts in tissues like bone or muscle)
The tumor must be at least 1.5 centimeters in size (about the size of a grape)
Must not be part of any vulnerable population groups (such as persons unable to give consent)

Who Cannot Join the Study?

Age under 18 years or over 65 years old
Patients who are unable to lie still in the PET/MR scanner (a combined imaging machine) for up to 60 minutes
Patients with claustrophobia (fear of confined spaces)
Patients with metal implants or devices not compatible with MRI (magnetic resonance imaging)
Pregnant or breastfeeding women
Patients with severe kidney dysfunction, as this may affect the processing of imaging substances
Patients with known allergies to the imaging substances used in the study
Patients who have received other experimental drugs within 30 days before the study
Patients who cannot provide informed consent
Patients with uncontrolled medical conditions that could interfere with the imaging procedures
Patients weighing more than 180 kg (397 lbs) due to scanner limitations
Patients with blood glucose levels above 200 mg/dL at the time of imaging

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Rigshospitalet	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	26.04.2022

Trial locations

Investigated drugs:

Hyperpolarized [1-13C]Pyruvate is an imaging agent used in magnetic resonance spectroscopy. It helps doctors see how cancer cells process nutrients differently from normal cells. When injected into the body, it allows visualization of metabolic processes in real-time, particularly how tumors break down pyruvate.

18F-FDG (18-Fluoro-deoxy-glucose) is a radioactive form of glucose used in PET imaging. It helps doctors see areas in the body where cells are using more glucose than normal, which is often a sign of cancer. The substance accumulates in cancer cells because they typically consume more glucose than healthy cells.

Both imaging agents are used together in this study to provide detailed information about tumor metabolism using two different but complementary imaging techniques (PET and MRI) at the same time.

Investigated diseases:

Breast cancer – A disease that begins when cells in the breast tissue start to grow abnormally and divide more rapidly than healthy cells. These cells typically form a mass or lump that can be felt in the breast tissue. The cancer can develop in different parts of the breast, including the ducts that carry milk, the glands that produce milk, or other breast tissues.

Neuroendocrine neoplasms – A group of tumors that develop from specialized cells called neuroendocrine cells, which have traits of both nerve cells and hormone-producing cells. These tumors can form in various parts of the body and may grow slowly or quickly. The cells can produce various hormones that affect body functions.

Lymphomas – A group of blood cancers that develop in the lymphatic system, which is part of the body’s immune system. These cancers begin in lymphocytes, which are white blood cells that help fight infection. The abnormal lymphocytes collect in lymph nodes and other tissues, forming tumors.

Sarcomas – A diverse group of cancers that develop in the body’s connective tissues, including bone, muscle, fat, blood vessels, and soft tissues. Unlike most other cancers that develop in organs, sarcomas can occur anywhere in the body where these connective tissues are found. These tumors develop from cells in these supportive tissues that begin to grow abnormally.

Trial ID:

2024-516131-28-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Combined Imaging with Hyperpolarized [1-13C]Pyruvate and Fludeoxyglucose (18F) for Cancer Detection in Patients with Breast Cancer, Neuroendocrine Tumors, Lymphomas, or Sarcomas

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?