Clinical trial · Observational
Assessment of Brain Cognitive Impairment in Breast Cancer
Integrated PET/MRI Study of Cognitive Impairment in Premenopausal Breast Cancer Patients After Chemotherapy or Endocrine Therapy
NCT05305092CI-TRIAL-00059635recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To explore the cognitive impairment caused by chemotherapy and endocrine therapy in premenopausal breast cancer patients and to find biomarkers with early predictive effect on this cognitive impairment by using multimodal integrated PET/MRI technology combined with psychobehavioral technology.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Chemo-brain | — | UNRESOLVED | — |
| Endocrine Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- chemotherapy
- description
- Premenopausal breast cancer patients receiving chemotherapy (including preoperative neoadjuvant chemotherapy) and endocrine therapy after surgery
- interventionNames
- Device: PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample
- label
- Endocrine therapy
- description
- Premenopausal breast cancer patients receiving endocrine therapy alone after surgery
- interventionNames
- Device: PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample
- label
- Healthy control
- description
- Healthy non-cancer controls
- interventionNames
- Device: PET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.