RecruitingNCT05305092
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
Sponsor
Tang-Du Hospital
Enrollment
90 participants
Start Date
May 31, 2022
Study Type
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Sex: FEMALE
Inclusion Criteria8
- 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 Criteria5
- 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.
Interventions
DEVICEPET/MRI, psychobehavioral tests and questionnaires, serum biomarkers and stool sample
Neuroimaging data were collected by integrated PET/MRI machine, and collected the psychobehavioral data, the serum and stool samples of participants.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05305092
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