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Status unknownNCT04334720Updated Apr 6, 2020

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

An observational study in Brown Fat and Muscle Metabolic and Differential Diagnosis, sponsored by Tang-Du Hospital. Status unknown at 1 site in China. Open to participants aged 15 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-06.

Sponsored by Tang-Du Hospital · Observational

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
300
Ages
15 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Brown Fat and Muscle Metabolic
  • Differential Diagnosis

Keywords

  • Psychological
  • Comprehensive treatment
  • Positron emission computed tomography/Magnetic resonance
03

In context

Lead sponsor

Tang-Du Hospital is the lead sponsor of 164 studies on the registry; 77 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

patients of the Tangdu hospital

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

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.
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • The control group

    Corresponding to the observation group, the time, sequence and protocol were consistent

Interventions

  • OtherComprehensive 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.

06

What researchers measure

Primary outcomes

  1. Change metabolism of glucose of M&F

    Glucose metabolic scores will be assessed with visual scale

    Time frame: Baseline, 1 day ( Contrast scanning)

  2. Change of the glucose metabolism area of M&F

    Five different anatomical locations (subphrenic, paravertebral, mediastinal, cervical, supraclavicular) will be assessed with visual.

    Time frame: Baseline, 1 day ( Contrast scanning)

  3. Change of activated M&F volume

    Activated M\&F volume before and after comprehensive treatment were evaluated by post-processing software

    Time frame: Baseline, 1 day ( Contrast scanning)

  4. Change of M&F SUVmax and SUVmean

    SUVmax and SUVmean scores will be measured by post-processing software.

    Time frame: Baseline, 1 day ( Contrast scanning)

  5. Change of anxiety symptoms

    Anxiety symptoms scores will be assessed with Hamilton Anxiety Scale.

    Time frame: Baseline, 1 day ( Contrast scanning)

  6. Change of sleep

    Sleep scores will be assessed with Pittsburgh sleep quality index one month before scanning

    Time frame: Baseline, 1 day ( Contrast scanning)

  7. 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

    Time frame: Baseline, 1 day ( Contrast scanning)

07

Study locations

1 of 1 sites recruiting
  • Tangdu Hospital
    Xi'an, Shaanxi 710038, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04334720
Lead sponsor
Tang-Du Hospital
Responsible party
Sponsor
First posted
Apr 6, 2020
Start date
Jul 1, 2019
Primary completion
Aug 1, 2021 (estimated)
Completion
Aug 1, 2023 (estimated)
Last update
Apr 6, 2020

Study contacts

Li Yunbo, MD
Contact
realmoco@163.com
15991771598
Yuan Menghui, PHD
Contact

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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