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

NCT ID: NCT04334720

Last Updated: 2020-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2023-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Brown Fat and Muscle Metabolic Differential Diagnosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Comprehensive treatment of tumor

Intervention Type OTHER

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

Comprehensive treatment of tumor

Intervention Type OTHER

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

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.


• 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.
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tang-Du Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tangdu Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Yunbo, MD

Role: CONTACT

15991771598

Yuan Menghui, PHD

Role: CONTACT

Facility Contacts

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Li Yunbo, MD

Role: primary

15991771598

Other Identifiers

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Fat & Muscle -No.1

Identifier Type: -

Identifier Source: org_study_id

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