NCT05305092Recruiting
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
Source: ClinicalTrials.gov · Last updated 13 Jul 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 90 (estimated)
- First submitted
- 6 Mar 2022
- Start date
- 31 May 2022
- Primary completion date
- 30 May 2027
- Lead sponsor
- Tang-Du Hospital
- Diseases
- Childhood cancers
- NCT number
- NCT05305092
What you commit to
- Study type: Observational
- Planned participants: 90
- From 31 May 2022 to the primary completion date, 30 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- MRI related contraindications: pacemakers, defibrillators, hearing aids, insulin pumps, drug dose control devices and other metal implants; patients with severe hyperthermia; patients with claustrophobia.
Other illness
- 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.
Who the study is looking for
- 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.
Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tangdu Hospital Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.