Clinical trial Recruiting at 1 site Observational Women only

Exploring cognitive impairment in breast cancer patients

Official title: Integrated PET/MRI Study of Cognitive Impairment in Premenopausal Breast Cancer Patients After Chemotherapy or Endocrine Therapy

Run by Tang-Du Hospital · NCT05305092 · Data updated 2026-11-12

This study is trying to see if certain brain changes in young women with breast cancer who are undergoing chemotherapy and hormone therapy can help predict memory and thinking problems, so doctors can choose better treatment plans.

Quick facts

Study typeObservational
SexWomen only
Enrollment90 (estimated)
SponsorTang-Du Hospital
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Xi'an, Shaanxi)
StatusRecruiting
StartedMay 31, 2022
Main results expectedMay 30, 2027
Study endsMay 30, 2027
Registry record updatedJuly 13, 2022
Trial IDNCT05305092 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are premenopausal women with primary stage I-II breast cancer who have not yet started treatment other than surgery.

Probably not a fit

Patients with central nervous system diseases, a history of malignancy, or conditions affecting cognitive function may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates cognitive impairment caused by chemotherapy and endocrine therapy in premenopausal women with breast cancer. It employs advanced multimodal integrated PET/MRI technology alongside psycho-behavioral assessments to observe changes in brain structure, function, and glucose metabolism. The goal is to identify biomarkers that can predict cognitive decline early, aiding in the rational selection of treatment plans for breast cancer patients. By understanding these cognitive effects, the study aims to improve patient care and outcomes.

Why it matters

Potential benefit: If successful, this study could lead to better treatment strategies that minimize cognitive impairment in breast cancer patients.

How similar studies have gone: Other studies have shown success in exploring cognitive impairment in cancer patients, but this specific approach using integrated PET/MRI technology is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients with primary stage I-II breast cancer.
* Premenopausal women (menopausal status determined by National Comprehensive Cancer Network Breast Cancer Guidelines criteria).
* No treatment other than surgery has been started (if neoadjuvant chemotherapy is required before surgery, enroll before chemotherapy starts).
* Eastern Cooperative Oncology Group score of 0-1 points.
* Can understand and complete various scales.
* Right handedness.
* Female subjects of childbearing potential must be willing to use a medically-approved high-efficiency contraceptive method (eg, intra-uterine device, birth control pill, or condom) for the duration of the study.
* Sign the informed consent and voluntarily participate in this clinical observation.

Exclusion Criteria:

* Central nervous system (CNS) disease, history of malignancy, chronic loss of consciousness, head trauma, and any disease affecting cognitive function.
* Current or former epilepsy, dementia, or learning disabilities.
* Past psychiatric history.
* Past history of malignancy.
* MRI related contraindications: pacemakers, defibrillators, hearing aids, insulin pumps, drug dose control devices and other metal implants; patients with severe hyperthermia; patients with claustrophobia.

Where it's running

  • Tangdu Hospital
    Xi'an, Shaanxi, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.