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Assessing the prognostic value of PSMA‑T4 SPECT/CT imaging in patients with triple‑negative breast cancer undergoing neoadjuvant therapy

InvestigationalNo placebo

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What is this trial about?

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

The study looks at patients with triple-negative breast cancer who are scheduled for surgery after receiving neoadjuvant therapy. As part of the study, participants will receive an injection of a substance called PSMA-T4 that is prepared in a kit and contains a tiny amount of radioactive material. After the injection, a special imaging procedure known as SPECT/CT will be performed to create pictures of the tumor and surrounding tissue.

The purpose of the study is to find out whether the images obtained with this test can predict how the cancer will respond to treatment. Participants will have the scan before starting therapy, then will follow the usual treatment plan, and after surgery a detailed tissue examination called histopathological analysis will be done. Blood samples will also be taken for a liquid biopsy to look for tumor‑related genetic material, and any side effects will be recorded using the CTCAE grading system.

The study will track the results of the tissue examination, the level of the injected substance taken up by the tumor, and any serious side effects. Information gathered will help researchers understand whether the imaging test provides useful prognostic information for this type of cancer.

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
Join the study
After signing the consent form, you become a participant in the trial that evaluates a special imaging test for triple‑negative breast cancer.
Step 2
Baseline assessment
The study team records your medical history, confirms the diagnosis of triple‑negative breast cancer, and checks that you meet all eligibility criteria.
Blood samples may be taken for future genetic testing.
Step 3
Receive the radiopharmaceutical injection
A kit called psma‑t4 is prepared with the radioactive substance technetium‑99m.
The injection contains a dose of 740 mbq (megabecquerel), which measures the amount of radioactivity.
The injection is given into a vein by a qualified professional.
Step 4
Imaging procedure
After the injection, you undergo a spect/ct scan, a type of imaging that combines a camera that detects the radioactivity with a CT (computed tomography) scanner that shows detailed pictures of your body.
The scan records how much of the tracer is taken up by the tumor, which helps assess its characteristics.
Step 5
Continue neoadjuvant therapy
You proceed with the planned neoadjuvant (pre‑surgery) treatment for breast cancer, which may include chemotherapy or other standard therapies.
The imaging results are used by the study team to evaluate their prognostic value, but they do not change your prescribed therapy.
Step 6
Surgery and tissue collection
After completing neoadjuvant therapy, you have radical surgery to remove the tumor.
Tissue samples are taken during the operation for detailed laboratory analysis.
Step 7
Laboratory analysis
The removed tissue is examined under a microscope (histopathology) and tested for the presence of the psma receptor using immunohistochemistry.
Blood collected earlier is analyzed as a liquid biopsy to look for genetic changes that may relate to the imaging findings.
Step 8
Monitoring for adverse events
Throughout the trial, you are monitored for any side effects, especially those of grade 3 or higher severity, which are serious but not necessarily life‑threatening.
Any serious adverse events are recorded and evaluated in relation to the tracer uptake seen on the scan.

Who can join the trial?

10 criteria

Have a confirmed diagnosis of triple‑negative breast cancer, meaning the cancer cells do not have estrogen receptors (ER) or progesterone receptors (PR) and do not show excess HER2 protein; this is shown by a tissue test called histopathology.
Show adequate health of major organs, as judged by recent blood tests and a physical exam.
Have test results that show no over‑expression of the HER2 protein (a score of 0 or 1+ on a test called immunohistochemistry) and no extra copies of the HER2 gene (a negative result on a test called in situ hybridization or FISH).
Be in a cancer stage that fits either: a tumor size classified as T1‑T4 with lymph‑node involvement classified as N1‑N2, or a tumor size T2‑T4 with no lymph‑node involvement (N0). The letters “T” describe the size of the main tumor and “N” describe whether cancer has spread to lymph nodes.
Be eligible for neoadjuvant therapy (treatment given before surgery). This includes anyone with lymph‑node involvement, or, if no lymph nodes are involved, a primary tumor that is larger than 2 cm.
Be at least 18 years old.
Identify as female.
Have an ECOG performance status of 0‑2, which means you are fully active (0) up to being able to care for yourself but unable to work (2).
Agree to take part in the study and sign a written consent form.
Have not received any treatment for an invasive cancer in the past five years.

Who cannot join the trial?

5 criteria

Not having a tissue test that proves the cancer is triple‑negative (histopathological confirmation means a lab examination of a sample to confirm the diagnosis).
Having triple‑negative breast cancer that has already spread to other parts of the body (distant metastases means cancer cells found far from the original tumor).
Having a medical reason that prevents the imaging test (contraindications) such as a known allergy (hypersensitivity) to the special radioactive drug (radiopharmaceutical [99mTc]Tc-PSMA‑T4) used in the scan (scintigraphy is a test that takes pictures of the inside of the body using a tiny amount of radioactive material).
Having any other health problem that the doctor believes would stop you from starting the pre‑surgery treatment (neoadjuvant therapy is treatment given before surgery to shrink the tumor).
Being pregnant or breastfeeding.

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Investigated drugs

PSMA‑T4 kit for Tc‑99m labelling is a diagnostic product used to make a special imaging agent that can be injected into a patient’s vein. Once prepared, the agent contains a tiny amount of a radioactive material called technetium‑99m, which helps doctors see certain cells during a SPECT/CT scan. In this trial, the imaging agent is used to look at the presence of PSMA‑T4 in tumors of patients with triple‑negative breast cancer. By showing how much of the agent gathers in the cancer, doctors hope to predict how the disease will behave and how well patients might respond to their upcoming treatments. This product is only for testing and does not act as a medication to treat the cancer.

What is already known about the treatment

PSMA-T4 - This product is supplied as a kit that is mixed with Technetium‑99m to create a radiopharmaceutical, which is then given to the patient by a single injection. It is currently an investigational agent and has not received full regulatory approval, being used mainly in clinical research studies. The main purpose is to help doctors see how much PSMA protein is present in tumors, and in this trial it is being tested to predict outcomes for patients with triple‑negative breast cancer. It works by the PSMA‑targeting molecule binding to the PSMA protein on cells, while the attached Technetium‑99m emits detectable radiation, and it is classified as a diagnostic radiopharmaceutical.

Investigated diseases

triple-negative breast cancer - This is a form of breast cancer that does not express estrogen receptors, progesterone receptors, or HER2 protein. Because it lacks these targets, the tumor cells often grow rapidly and can invade nearby tissues. The disease may initially appear as a palpable lump or an abnormal finding on imaging. As it progresses, cancer cells can spread to regional lymph nodes and later to distant organs such as bone, liver, or lung. The clinical course generally moves from a localized tumor to regional spread and ultimately to metastatic disease if not controlled.