Clinical trial NCT04334720: PET/MRI Study on Changes of Fat and Muscle Metabolism.
Official title: PET/MRI Study on the Effects of Psychosocial on Fat and Muscle Metabolism for Malignant Tumor Patient After Comprehensive Treatment.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brown Fat and Muscle Metabolic
Differential Diagnosis
Keywords: Psychological
Comprehensive treatment
Positron emission computed tomography/Magnetic resonance
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 300
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients of the Tangdu hospital

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Inclusion Criteria for Healthy Control Participants:

• Clinical diagnosis of Healthy Control

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change metabolism of glucose of M&F
timeFrame: Baseline, 1 day ( Contrast scanning)
measure: Change of the glucose metabolism area of M&F
timeFrame: Baseline, 1 day ( Contrast scanning)
measure: Change of activated M&F volume
timeFrame: Baseline, 1 day ( Contrast scanning)
measure: Change of M&F SUVmax and SUVmean
timeFrame: Baseline, 1 day ( Contrast scanning)
measure: Change of anxiety symptoms
timeFrame: Baseline, 1 day ( Contrast scanning)
measure: Change of sleep
timeFrame: Baseline, 1 day ( Contrast scanning)
measure: Change of metabolism of glucose in the M&F
timeFrame: Baseline, 1 day ( Contrast scanning)
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
Study officials:
References: