Study of 64Cu-DOTATATE and 18F-FDG PET/CT imaging to predict disease progression in patients with neuroendocrine neoplasms

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What is this study about?

This study focuses on patients with Neuroendocrine Neoplasms (tumors that develop from cells of the hormone system). The research uses two different imaging substances: 64Cu-DOTATATE and 18F-FDG, which are special solutions given through an injection into a vein. These substances help create detailed images of tumors using a special type of scanning called PET/CT (a combination of two imaging techniques that produces detailed pictures of the body’s internal structures).

The purpose of this study is to develop new ways to predict how long patients with neuroendocrine neoplasms might remain stable without their disease getting worse. This will be done by analyzing measurements from combined scans using both imaging substances. During the study, participants will receive both types of imaging solutions and undergo PET/CT scanning.

Both imaging substances are given as single injections into a vein. 64Cu-DOTATATE attaches to specific receptors found on neuroendocrine tumors, while 18F-FDG helps show how active the tumor cells are. The combination of these two different types of scans provides doctors with more complete information about the tumor’s characteristics and behavior.

1 Initial imaging scan – first day

You will receive an intravenous injection of 64Cu-DOTATATE, which is a special imaging solution that helps detect neuroendocrine tumors.

A PET/CT scan (a detailed body imaging test) will be performed to create detailed pictures of your body’s tissues.

2 Second imaging scan – same day

You will receive an intravenous injection of 18F-FDG (fluorodeoxyglucose), another imaging solution.

A second PET/CT scan will be performed to obtain additional images of your body’s tissues.

3 Follow-up period

Your health status will be monitored to track how long you remain without disease progression.

The monitoring period will continue until December 31, 2026.

The medical team will record information about your overall survival and disease progression.

4 Data analysis

The images from both scans will be analyzed to measure tumor characteristics.

The results will be used to create predictive models about disease progression.

The scan results will also help determine if you might be suitable for additional treatments in the future.

Who Can Join the Study?

Must be 18 years of age or older
Must have a confirmed diagnosis of gastro-pancreatic neuroendocrine neoplasm (a type of tumor that develops in the digestive system or pancreas) through tissue examination, or have tumor spread (metastases) suggesting this type of cancer
Must be able to read and understand patient information and provide informed consent
Must have a WHO Performance status of 0-2 (this measures a patient’s ability to care for themselves, where 0 means fully active and 2 means able to do light activities but unable to work)
Both men and women can participate in this study

Who Cannot Join the Study?

Age below 18 years or above 65 years
Inability to undergo PET/CT scanning (a type of medical imaging that combines two scanning techniques)
Known allergies or hypersensitivity to the imaging agents (18FDG and 64Cu-DOTATATE)
Pregnancy or breastfeeding
Inability to provide informed consent
Previous participation in another clinical trial within the past 30 days
Severe claustrophobia (fear of confined spaces) that would prevent scanning
Metal implants or devices that could interfere with imaging
Inability to lie still for the duration of the scanning procedure (approximately 30-45 minutes)
Serious medical conditions that could interfere with study participation
History of other active cancers in the past 5 years (except for adequately treated non-melanoma skin cancer)

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	17.01.2023

Trial locations

Investigated drugs:

64Cu-DOTATATE is a radioactive tracer used in PET/CT imaging. It specifically binds to receptors commonly found on neuroendocrine tumors, helping doctors to visualize these tumors and their spread throughout the body. This imaging agent helps to create detailed pictures of where neuroendocrine tumors are located.

18F-FDG (fluorodeoxyglucose) is also a radioactive tracer used in PET/CT imaging. It works by showing areas in the body that use a lot of glucose (sugar), which is common in fast-growing cancer cells. This imaging agent helps doctors see how active the tumor cells are and can help determine how aggressive the cancer might be.

Both tracers are used together in this study to provide complementary information about neuroendocrine tumors, helping doctors better understand the disease and predict how patients might respond to treatment.

Investigated diseases:

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, most commonly in the digestive tract, pancreas, or lungs. Neuroendocrine neoplasms grow at different rates, with some developing slowly while others progress more rapidly. These tumors may produce excess hormones that can cause distinct symptoms depending on the type of hormone being overproduced. The condition varies greatly from person to person in terms of location, behavior, and symptoms.

Trial ID:

2024-516156-18-00

Protocol code:

AK_NEN_DOTA-FDG_21

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of 64Cu-DOTATATE and 18F-FDG PET/CT imaging to predict disease progression in patients with neuroendocrine neoplasms

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?