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 study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	01.04.2024

Trial locations

Investigated drugs:

(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

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.

Investigated diseases:

Hormone receptor positive breast cancer

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.

Trial ID:

2023-508066-15-00

NCT ID:

NCT06335069

Trial Phase:

Therapeutic exploratory (Phase II)

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Study Comparing 18F-FDG and 68Ga-FAPI-46 for PET Scans in Patients with Hormone-Positive Breast Cancer

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?