PET/MRI Study on Changes of Fat and Muscle Metabolism.

Differential Diagnosis Clinical Trial

Official title:

PET/MRI Study on the Effects of Psychosocial on Fat and Muscle Metabolism for Malignant Tumor Patient After Comprehensive Treatment.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04334720
• Other study ID #: Fat & Muscle -No.1
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: August 1, 2023

Study information

• Verified date: April 2020
• Source: Tang-Du Hospital
• Contact: Li Yunbo, MD
• Phone: 15991771598
• Email: realmoco[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brown Fat and Muscle Metabolic
• Differential Diagnosis

Intervention

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.

Locations

Country	Name	City	State
China	Tangdu Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change metabolism of glucose of M&F	Glucose metabolic scores will be assessed with visual scale	Baseline, 1 day ( Contrast scanning)
Primary	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)
Primary	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)
Primary	Change of M&F SUVmax and SUVmean	SUVmax and SUVmean scores will be measured by post-processing software.	Baseline, 1 day ( Contrast scanning)
Primary	Change of anxiety symptoms	Anxiety symptoms scores will be assessed with Hamilton Anxiety Scale.	Baseline, 1 day ( Contrast scanning)
Primary	Change of sleep	Sleep scores will be assessed with Pittsburgh sleep quality index one month before scanning	Baseline, 1 day ( Contrast scanning)
Primary	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)