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Study Comparing 18F-FDG and 68Ga-FAPI-46 for PET Scans in Patients with Hormone-Positive Breast 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 hormone-positive breast cancer, a type of breast cancer that grows in response to hormones like estrogen. The study is comparing two different substances used in imaging tests called PET scans, which help doctors see how the cancer is behaving in the body. The substances being compared are 18F-FDG and 68Ga-FAPI-46. These are special tracers that are injected into the body to highlight cancer cells during the scan.

The purpose of the study is to find out how well 68Ga-FAPI-46 works compared to 18F-FDG in detecting cancer in patients with ER-positive breast cancer, which means the cancer cells grow in response to the hormone estrogen. The study will involve patients undergoing PET scans with both tracers to see which one provides more accurate information about the cancer.

Participants in the study will receive injections of the tracers and then have PET scans performed. The study will look at how many cancer spots are detected by each tracer and whether one tracer finds more spots than the other. This information will help doctors understand which tracer might be better for imaging hormone-positive breast cancer in the future.

The research process

The trial runs in 6 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, the patient must have a confirmed diagnosis of hormone-positive breast cancer. The patient should have a primary tumor larger than 5 cm or axillary lymph node metastases.
The patient must provide written informed consent to participate in the study.
Step 2
Initial imaging procedure
The patient will undergo an initial imaging procedure using 18F-FDG PET/CT or 18F-FDG PET/MRI. This step is necessary for staging the cancer.
Step 3
Administration of 68Ga-FAPI-46
The patient will receive an injection of 68Ga-FAPI-46, which is a solution for injection or infusion. This is administered as an intravenous bolus.
The purpose of this step is to use 68Ga-FAPI-46 as a PET tracer to compare its accuracy with 18F-FDG.
Step 4
Imaging with 68Ga-FAPI-46
After the administration of 68Ga-FAPI-46, the patient will undergo a PET scan. This scan will help in detecting lesions that may not have been visible with the previous 18F-FDG PET scan.
Step 5
Comparison of imaging results
The results from the 18F-FDG PET and 68Ga-FAPI-46 PET scans will be compared. The primary goal is to identify any lesions detected by one tracer but not the other.
Additionally, the study will compare the number of lesions detected on 68Ga-FAPI-46 PET/CT versus 68Ga-FAPI-46 PET/MRI.
Step 6
Completion of study participation
The patient's participation in the study will conclude after the imaging results have been analyzed and compared.
The study is expected to continue until March 2027, with recruitment starting in April 2024.

Who can join the trial?

7 criteria

The patient must be a female.
The patient must have a confirmed diagnosis of ER+ breast cancer. This means the cancer cells have receptors for the hormone estrogen, which can help the cancer grow.
The patient must have been diagnosed with locally advanced breast cancer. This means the primary tumor is larger than 5 cm, or there are cancer cells in the lymph nodes under the arm.
The patient may also have recurrent breast cancer, which means the cancer has come back after treatment.
The patient must be undergoing a specific type of imaging test called 18F-FDG PET/CT or 18F-FDG PET/MRI for staging. These are special scans that help doctors see how far the cancer has spread.
The patient must be willing and able to participate in the study procedures.
The patient must have given written informed consent. This means they have been informed about the study and agree to participate.

Who cannot join the trial?

4 criteria

Only women can participate in this study. Men are not eligible.
Participants must have **hormone-positive breast cancer**. This means the cancer grows in response to hormones like estrogen or progesterone.
Participants must be within certain age ranges, typically adults and older adults.
Individuals who are considered part of a **vulnerable population** are not eligible. This usually refers to groups who may need special protection, like children or those unable to give consent.

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Verified sites

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University Hospital Maastricht
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Maastricht, The Netherlands

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Investigated drugs

18F-FDG
is a type of imaging agent used in PET scans. It helps doctors see how tissues and organs are functioning. In this study, it is used to detect cancer activity in patients with ER-positive breast cancer.
68Ga-FAPI-46
is another imaging agent used in PET scans. It is being tested in this study to see if it can provide more accurate images of cancer activity in patients with ER-positive breast cancer compared to 18F-FDG.

(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-Cyano-4,4-Difluoropyrrolidin-1-Yl)-2-Oxoethylcarbamoyl)-Quinolin-6-Yl)(Methyl)Amino)-Propyl)Piperazin-1-Yl)-2-Oxoethyl)-68Ga-[1,4,7,10]-Tetraazacyclododecane-1,4,7-Triyl)Triacetate

What is already known about the treatment

68Ga-FAPI-46
This medication is administered as an injection and used as a PET tracer in imaging studies. It is currently being investigated in clinical trials to assess its effectiveness in detecting hormone-positive breast cancer. The main therapeutic indication is to improve the accuracy of cancer imaging. At the molecular level, 68Ga-FAPI-46 targets fibroblast activation protein, which is often overexpressed in cancerous tissues, allowing for better visualization of tumors. It is classified as a radiopharmaceutical used in diagnostic imaging.
18F-FDG
This medication is also administered as an injection and serves as a PET tracer in medical imaging. It is widely used in clinical practice and literature for detecting various types of cancer, including hormone-positive breast cancer. The primary therapeutic indication is to identify and monitor cancerous tissues. Its mechanism of action involves mimicking glucose, which is taken up by cells, allowing for the detection of areas with high metabolic activity, such as tumors. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Hormone-positive breast cancer – This type of breast cancer is characterized by the presence of receptors for hormones like estrogen or progesterone on the surface of the cancer cells. These hormones can promote the growth of the cancer. The disease often begins as a small lump or mass in the breast tissue, which may be detected through a mammogram or physical examination. Over time, the cancer can grow and potentially spread to nearby lymph nodes or other parts of the body. The progression of the disease can vary, with some cases remaining localized while others may become more advanced. Hormone-positive breast cancer is one of the more common types of breast cancer, particularly in postmenopausal women.