All studies
AuthorisedPhase II and Phase III (Integrated)Interventional

Prognostic value assessment of PSMA-T4 examination in the group of patients with triple-negative breast cancer (TNBC) qualified to radical therapy

Triple-negative breast cancer can be difficult to treat and needs clear imaging. Researchers are testing a specialised scan using a tracer called PSMA-T4, combined with a tiny amount of medical radiation (Tc-99m). This tracer attaches to specific markers found on breast cancer cells and their blood vessels, making them visible on special cameras. In this trial, women who are planning to have standard curative treatment, such as surgery, will receive the PSMA-T4 scan. Doctors will compare the scan pictures with the tissue removed during surgery to see how accurately the scan detected the cancer. They will also run blood tests to look for cancer signals and track safety. Taking part helps researchers learn if this scan can improve how doctors assess and plan treatment for triple-negative breast cancer in the future.

At a glance

Status
Authorised
Phase
Phase II and Phase III (Integrated)
Sponsor
Narodowe Centrum Badan Jadrowych
Enrolment target
100
Start
12 Aug 2026

What is this study about?

Triple-negative breast cancer is a type of breast cancer that does not have the three common receptors (oestrogen, progesterone, or HER2) often found on breast tumours. Because of this, it does not respond to hormone therapies and often requires surgery, chemotherapy, or radiotherapy. Getting a clear picture of the tumour and understanding how it grows is vital for planning the best possible care.

This study looks at a new type of imaging scan. Patients are given an injection containing a tracer called PSMA-T4, which carries a tiny, safe dose of a radioactive substance known as Technetium-99m (Tc-99m). This tracer is designed to seek out a protein called PSMA, which is often found in the blood vessels feeding breast tumours. A special camera then detects the tracer, producing detailed pictures of the cancer.

The main aim is to see how well these scan images match what doctors find when they examine tumour tissue in the laboratory after surgery. Researchers will also test blood samples for tiny fragments of cancer DNA, known as a liquid biopsy. By linking the scan results to laboratory tests, the study team hopes to discover whether PSMA-T4 scans can help predict how the cancer will respond to treatment and assist doctors in personalising care for future patients.

Key takeaways

  • Tests a specialised PSMA-T4 scan in women with triple-negative breast cancer.
  • Aims to see if the scan can clearly detect cancer cells and predict tumour behaviour.
  • The scan results will be compared with tissue removed during your planned surgery.
  • Involves a tracer injection, imaging scans, and routine blood tests.
  • Participation is completely optional and does not replace your normal cancer treatment.

Who may be eligible?

This trial is designed for adult women who have been diagnosed with triple-negative breast cancer and are scheduled to undergo standard, curative treatment (such as surgery).

To be considered, you must be 18 years of age or older and generally well enough to undergo standard hospital scans and cancer procedures. Because the study focuses on a specific stage of treatment, your medical team will confirm whether your planned therapy qualifies.

You may not be eligible if you are pregnant, breastfeeding, or if you have medical conditions that prevent you from having radioactive tracer injections or scanning. Your hospital specialist can review your complete medical records to see if this trial suits your personal situation.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I am a woman aged 18 or older.
  2. I have been diagnosed with triple-negative breast cancer.
  3. I am scheduled to have curative treatment, such as surgery.
  4. I am able to attend extra hospital visits for scans and blood tests.
  5. I am not pregnant or breastfeeding.
Answer every question to see your result.

What does participation involve?

If you decide to take part, you will have an extra hospital visit for the PSMA-T4 scan before your planned surgery. You will receive an injection of the tracer into a vein in your arm, followed by a waiting period while the tracer travels through your body. You will then lie flat inside a scanner while it takes detailed pictures of your chest.

During your visits, the research team will take blood samples to look at genetic markers related to your cancer. Your planned cancer surgery will go ahead as arranged by your surgical team. After surgery, the doctors will test the tissue that was removed to compare it with your earlier scan. The research team will also check in with you to monitor any potential side effects. In total, your participation will mainly take place around the time of your surgery, with short follow-up checks afterwards.

Potential risks and benefits

Taking part may not directly improve your own health outcome, but it could help doctors understand your tumour in greater detail and help improve care for other women with breast cancer in the future. The risks include mild discomfort or bruising from the injection needle, and a small dose of radiation from the tracer, similar to other standard nuclear medicine scans. Allergic reactions are rare but possible. Taking part is entirely voluntary; you can leave the study at any time without your regular NHS medical care being affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • —
    Unverified
    Poland

Common questions

Will taking part delay my planned cancer treatment?

No. The scan is scheduled to fit alongside your existing care plan so that your surgery and treatment are not delayed.

Is the radioactive tracer dangerous?

The tracer uses a very low dose of radiation (Tc-99m) that is routinely used in hospital scans and naturally leaves your body within a couple of days.

Does the scan hurt?

The scan itself is painless. You will only feel a quick scratch when the small needle is placed in your arm for the injection.

Will I still receive standard breast cancer treatment?

Yes. This study evaluates an imaging method and does not replace your standard surgery, chemotherapy, or radiotherapy.

Can I change my mind after joining?

Yes. You have the right to withdraw from the trial at any point, and your normal treatment will continue as usual.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.