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PET scans probe whether brain inflammation fuels 'chemo brain' in breast cancer

NCT ID NCT04364672

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time

Summary

This study uses a special PET scan to measure brain inflammation in women with stage II–III breast cancer before and after chemotherapy. The goal is to see whether higher levels of inflammation are linked to memory and thinking problems, often called 'chemo brain.' Twenty women will undergo two PET scans and cognitive tests to explore this possible connection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a radioactive tracer called [18F]DPA-714, given as an injection for PET scans
What this could lead to
If it works, this could help explain why some breast cancer patients experience 'chemo brain' and point toward ways to prevent or treat it.
What could go wrong
This is a very early, small study (20 people) that only looks at brain scans and thinking tests — it cannot prove that inflammation causes cognitive problems or lead to any treatment on its own.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Expected to start

Jun 2025

An estimate. Start dates often move.

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 18 years of age or older 2. Female gender 3. Newly diagnosed treatment naïve women with stage II-III breast cancer that meet the following * Stage IIA: Any 1 of these conditions: * There is no evidence of a tumor in the breast, but the cancer has spread to 1 to 3 axillary lymph nodes. It has not spread to distant parts of the body. (T0, N1, M0) * The tumor is 20 mm or smaller and has spread to the axillary lymph nodes (T1, N1, M0) * The tumor is larger than 20 mm but not larger than 50 mm and has not spread to the axillary lymph nodes (T2, N0, M0) * Stage IIb: Either of these conditions * The tumor is larger than 20 mm but not larger than 50 mm and has spread to 1 to 3 axillary lymph nodes (T2, N1, M0) * The tumor is larger than 50 mm but has not spread to the axillary lymph nodes (T3, N0, M0) * Stage IIIA: The cancer of any size has spread to 4 to 9 axillary lymph nodes or to internal mammary lymph nodes. It has not spread to other parts of the body (T0, T1, T2, or T3, N2, M0. Stage IIIA may also be a tumor larger than 50 mm that has spread to 1 to 3 axillary lymph nodes (T3, N1, M0) 4. English is the primary language 5. Planned neoadjuvant chemotherapy that includes a taxane and/or an anthracycline drug as part of the treatment regimen. Exclusion Criteria: 1. Contraindications to PET/MRI, including claustrophobia 2. Low-affinity binder for TSPO ligands when genotyping is available prior to PET imaging 3. Pregnancy 4. Lactation 5. Individuals who are unable to participate in the imaging portion due to the severity of their medical condition 6. Chronic infectious disease (e.g., HIV, HCV) 7. Chronic inflammatory disease (e.g., fibromyalgia, MS, etc) or autoimmune disease 8. Viral or bacterial illness requiring medical attention and/or antibiotics within 1 month of study participation 9. Blood or blood clotting disorder 10. Cancer that has metastasized to the brain 11. Positive urine β-hCG test day of the procedure or a serum-hCG test within 48 hours prior to the administration of \[18F\]DPA-714 12. Currently enrolled in a clinical trial utilizing experimental therapies. 13. Prior brain tumor or other neurological condition known to affect cognition 14. A diagnosis of dementia unrelated to cancer

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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