PET/MRI Study on Changes of Fat and Muscle Metabolism.
PET/MRI Study on the Effects of Psychosocial on Fat and Muscle Metabolism for Malignant Tumor Patient After Comprehensive Treatment.
1 other identifier
observational
300
1 country
1
Brief Summary
False positives for Brown Fat \& Muscle（F\&M） always affect the evaluation of metabolic disease treatment. Recently, using PET/CT，international journals such as Journal of Nuclear Medicine reported that the amount of active brown fat was correlated with renal creatinine clearance and subject to regulation by atrial natriuretic peptide in addition to association of season and temperature. At present，studies based on PET/CT have shown that elimination of the above factors, brown fat(even muscle) will still appear false positive metabolism in tumor patients. In view of the basis of Positron emission computed tomography/Magnetic resonance (PET/MRI) brain function research，our team speculate that it may be related to psychological or cortex metabolism. And there is a lack of studies on the correlation between the psychosocial，cortex structure and metabolism. Therefore, it suggests that，combination of structure and metabolism，PET/MRI will play a role in studying the effects of psychological on F\&M false-positive metabolism in malignant patients. In this project, the investigators intend to observe the changes of F\&M metabolism with psychological and cortex metabolism after comprehensive treatment in malignant patient by combining PET/MRI. The relationship between F\&M metabolism and psychological will be deeply analyzed to provide scientific basis for the development of the differential diagnosis and assessment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 2, 2020
CompletedFirst Posted
Study publicly available on registry
April 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedApril 6, 2020
April 1, 2020
2.1 years
April 2, 2020
April 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Change metabolism of glucose of M&F
Glucose metabolic scores will be assessed with visual scale
Baseline, 1 day ( Contrast scanning)
Change of the glucose metabolism area of M&F
Five different anatomical locations (subphrenic, paravertebral, mediastinal, cervical, supraclavicular) will be assessed with visual.
Baseline, 1 day ( Contrast scanning)
Change of activated M&F volume
Activated M\&F volume before and after comprehensive treatment were evaluated by post-processing software
Baseline, 1 day ( Contrast scanning)
Change of M&F SUVmax and SUVmean
SUVmax and SUVmean scores will be measured by post-processing software.
Baseline, 1 day ( Contrast scanning)
Change of anxiety symptoms
Anxiety symptoms scores will be assessed with Hamilton Anxiety Scale.
Baseline, 1 day ( Contrast scanning)
Change of sleep
Sleep scores will be assessed with Pittsburgh sleep quality index one month before scanning
Baseline, 1 day ( Contrast scanning)
Change of metabolism of glucose in the M&F
Accumulation of 18F-FDG will be analyzed by treatment-related, psychology-related and intervention-related Positron emission tomography/ Magnetic resonance
Baseline, 1 day ( Contrast scanning)
Study Arms (3)
Observation group of positive F&M
The baseline PET/MR scan was performed before comprehensive treatment, and the contrast scan was performed after treatment and the sequence and protocol was consistent. Get psychological assessment before and after treatment and the time interval shall not exceed half a year
Observation group of no abnormal changes in F&M
The baseline PET/MR scan was performed before comprehensive treatment, and the contrast scan was performed after treatment and the sequence and protocol was consistent. Get psychological assessment before and after treatment and the time interval shall not exceed half a year
The control group
Corresponding to the observation group, the time, sequence and protocol were consistent
Interventions
According to the pathologic types and TNM stage of tumor，specialists chose one or more of the interventions in surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy.
Eligibility Criteria
patients of the Tangdu hospital
You may qualify if:
- Clinical diagnosis of malignant tumor
- Have not yet been receiving comprehensive treatment and should begin within one month
- Fasting glucose of diabetic patients is controlled below 11.1 mmol/L.
- Clinical diagnosis of Healthy Control
You may not qualify if:
- Fasting glucose ≥11.1mmol/L
- History of endocrine disease (such as chronic glomerulonephritis, Addison's disease)
- Neurological signs and/or history of neurological disease
- Have begun comprehensive treatment
- Presence of magnetically active objects in the body
- Claustrophobia or any other medical condition that would preclude the participant from lying in the PET/MRI scanner for approximately 40 mins.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tang-Du Hospitallead
Study Sites (1)
Tangdu Hospital
Xi'an, Shaanxi, 710038, China
Central Study Contacts
Yuan Menghui, PHD
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 2, 2020
First Posted
April 6, 2020
Study Start
July 1, 2019
Primary Completion
August 1, 2021
Study Completion
August 1, 2023
Last Updated
April 6, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share