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Phase II Study of [68Ga]Ga-FAP-2286 PET/CT for Staging and Restaging Newly Diagnosed Primary Breast Cancer Patients

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on individuals diagnosed with Primary breast cancer and evaluates a special imaging test that uses a tiny amount of a radioactive substance to create detailed pictures of the body. The radioactive substance, known as [⁶⁸Ga]Ga-HKG301, is provided in the test product AAA514 and is given through an intravenous line. The images are obtained with a combined scanner called PET/CT, which merges two types of pictures to show both the structure and activity of tissues.

The purpose of the study is to determine how well this imaging test can identify the original location of the cancer and any spread, as well as to assess its ability to detect cancer that may return after treatment. Participants will receive an injection of the radioactive substance, wait a short period for it to circulate, and then undergo the scan. A follow‑up scan may be performed later to see any changes. “Staging” means finding the size and spread of cancer at diagnosis, while “restaging” refers to checking again after therapy. “Sensitivity” describes the test’s ability to correctly find cancer when it is present, “specificity” means correctly showing no cancer when it is absent, “predictive values” indicate how likely the results are to be correct, and “accuracy” reflects the overall correctness of the test.

The scan results will be compared with the tissue analysis that doctors perform after surgery to see if they match. The study will also look at whether the imaging changes the doctor’s view of the cancer stage, leads to different treatment choices, or reveals unexpected findings. Throughout the study, safety checks will be carried out to ensure that the injection and scanning procedure are well tolerated.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and consent
After agreeing to take part, you sign the consent form and become a participant in the study.
Step 2
Baseline evaluation
Clinical information about your breast cancer is recorded, and any required laboratory tests are performed before receiving the study medication.
Step 3
Administration of study medication
The investigational product aaa514 (containing the substance fap‑2286) is prepared as a kit for radiopharmaceutical use.
A single dose of 240 mbq (megabecquerel) is injected into a vein.
The injection is given intravenously, which means the medicine goes directly into the bloodstream.
Step 4
Pet/ct imaging
Shortly after the injection, you undergo a ga‑hkg301 pet/ct scan.
The scan combines a positron emission tomography (pet) image that shows where the radiopharmaceutical has gathered with a computed tomography (ct) image that shows the body’s anatomy.
The purpose of the scan is to stage the cancer (determine how far it has spread) or to restage it later if treatment has been given.
Step 5
Assessment of imaging results
The images are evaluated for sensitivity, specificity, predictive values and overall accuracy in detecting breast cancer lesions.
The results may influence the clinical stage assigned to the disease.
Step 6
Safety monitoring
You are observed for any immediate or delayed reactions to the radiopharmaceutical.
Adverse events are recorded and evaluated throughout the study period.
Step 7
Follow‑up imaging (if required)
A second ga‑hkg301 pet/ct scan may be performed after treatment to assess response and to restage the disease.
The same dose and procedure are used as for the initial scan.
Step 8
Study completion
After the final assessments, your participation in the trial ends.
All data collected during the study are used to evaluate the effectiveness and safety of the investigational product.

Who can join the trial?

5 criteria

Be 18 years of age or older.
Have a new diagnosis of primary breast cancer that has been confirmed by a biopsy (a small tissue sample taken to check for cancer cells).
Be able to read and understand the Danish language.
Be capable of giving written informed consent (signing a document that shows you understand the study and agree to take part).
Will be scheduled for a routine [¹⁸F]FDG PET/CT scan (a special imaging test that uses a small amount of radioactive sugar to create detailed pictures of the body) as part of your normal medical evaluation.

Who cannot join the trial?

4 criteria

Pregnant or lactating women – you cannot join if you are currently pregnant (carrying a baby) or breastfeeding your baby.
Unable to take part in the scan – you must be able to lie still and follow the instructions for the imaging test; if you cannot do this, you cannot join.
Receiving cancer treatment for a different cancer – if you are currently being treated for another type of cancer, you are not eligible.
History of allergic reactions or hypersensitivity to the study drug – if you have previously had an allergy or an overly strong reaction to the compound called [⁶⁸Ga]Ga-HKG301, you cannot participate.

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Verified sites

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Odense University Hospital
Odense, Denmark

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Investigated drugs

AAA514 is a radiopharmaceutical used for PET/CT scans. It contains a special radioactive substance that is injected into a vein. Once inside the body, it helps a PET scanner see areas where breast cancer may be present or returning. The medicine does not treat the cancer itself; it simply makes the images clearer so doctors can better understand the stage of the disease and plan appropriate treatment.

What is already known about the treatment

FAP-2286 - It is given by intravenous injection as a kit that is prepared right before use, delivering a small amount of radioactivity (240 MBq). The substance is an experimental radiopharmaceutical that is currently being studied in clinical trials and is not yet approved for routine medical use. It is used to image primary breast cancer, helping doctors see the spread of the disease through PET/CT scans. The molecule binds to fibroblast activation protein on tumor‑associated cells and carries gallium‑68, a radioactive tracer that emits signals captured by the scanner; it belongs to the class of diagnostic radiopharmaceuticals.

Investigated diseases

Primary breast cancer - Primary breast cancer is a malignant growth that begins in the cells of the breast. It may enlarge within the breast tissue and involve nearby lymph nodes. Over time it can extend beyond the breast to other organs such as bone, liver, or lungs. The disease often starts as a small lump or an area of thickening. As it grows, it can change the shape of the breast or cause skin changes. Early spread is called regional spread, while later spread involves distant sites.