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.

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.

Study Overview

• Status: Recruiting
• Conditions: Brown Fat and Muscle Metabolic; Differential Diagnosis
• Intervention / Treatment: Other: Comprehensive treatment of tumor

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Li Yunbo, MD; Phone Number: 15991771598; Email: realmoco@163.com
• Study Contact Backup: Name: Yuan Menghui, PHD

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710038
      • Recruiting
      • Tangdu Hospital
      • Contact: Li Yunbo, MD; Phone Number: 15991771598; Email: realmoco@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients of the Tangdu hospital

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Comprehensive treatment of tumor; 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.
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	Other: Comprehensive treatment of tumor; 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.
The control group; Corresponding to the observation group, the time, sequence and protocol were consistent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: April 2, 2020
• First Submitted That Met QC Criteria: April 3, 2020
• First Posted (Actual): April 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Psychological; Comprehensive treatment; Positron emission computed tomography/Magnetic resonance
• Additional Relevant MeSH Terms: Pathologic Processes; Disease
• Other Study ID Numbers: Fat & Muscle -No.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No