Brown Fat and Muscle MetabolicNCT04334720
PET/MRI Study on Changes of Fat and Muscle Metabolism.
An observational study of Brown Fat and Muscle Metabolic and Differential Diagnosis, run by Tang-Du Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Brown Fat and Muscle Metabolic, Differential Diagnosis
- What is being tested?
- Comprehensive treatment of tumor
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: patients of the Tangdu hospital
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Yuan Menghui, PHD contact
China1 site, 1 recruiting
- Recruiting
Tangdu Hospital
Xi'an, Shaanxi, 710038
Li Yunbo, MD, 15991771598, realmoco@163.com
About this study
Official title: 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.
- Being tested
- Comprehensive treatment of tumor
- Keywords
- Psychological, Comprehensive treatment, Positron emission computed tomography/Magnetic resonance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive treatment of tumorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Comprehensive treatment of tumor | |
| The control group | Corresponding to the observation group, the time, sequence and protocol were consistent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change metabolism of glucose of M&F
Glucose metabolic scores will be assessed with visual scale
Measured: 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.
Measured: 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
Measured: Baseline, 1 day ( Contrast scanning)
Change of M&F SUVmax and SUVmean
SUVmax and SUVmean scores will be measured by post-processing software.
Measured: Baseline, 1 day ( Contrast scanning)
Change of anxiety symptoms
Anxiety symptoms scores will be assessed with Hamilton Anxiety Scale.
Measured: Baseline, 1 day ( Contrast scanning)
Change of sleep
Sleep scores will be assessed with Pittsburgh sleep quality index one month before scanning
Measured: 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
Measured: Baseline, 1 day ( Contrast scanning)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start1 Jul 2019
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brown Fat and Muscle MetabolicStudies of the same condition, open and under way.
- More trials run by Tang-Du HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334720
- Sponsor's protocol ID
- Fat & Muscle -No.1
- Status last verified
- Apr 2020
- First submitted
- 2 Apr 2020
- Last updated
- 6 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET/MRI Study on the Effects of Psychosocial on Fat and Muscle Metabolism for Malignant Tumor Patient After Comprehensive Treatment.
- ClinicalTrials.gov ID
- NCT04334720
- Acronym / sponsor ID
- Fat & Muscle -No.1
- Keywords
- Psychological, Comprehensive treatment, Positron emission computed tomography/Magnetic resonance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 6 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Observation group of positive F&M | – | Other: Comprehensive treatment of tumorThe 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 |
| Observation group of no abnormal changes in F&M | – | Other: Comprehensive treatment of tumorThe 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 |
| The control group | – | –Corresponding to the observation group, the time, sequence and protocol were consistent |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- patients of the Tangdu hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive treatment of tumorAccording 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. | Other | Observation group of no abnormal changes in F&M, Observation group of positive F&M |
Primary outcome
Change metabolism of glucose of M&F
Time frame: Baseline, 1 day ( Contrast scanning)
Glucose metabolic scores will be assessed with visual scale
Change of the glucose metabolism area of M&F
Time frame: Baseline, 1 day ( Contrast scanning)
Five different anatomical locations (subphrenic, paravertebral, mediastinal, cervical, supraclavicular) will be assessed with visual.
Change of activated M&F volume
Time frame: Baseline, 1 day ( Contrast scanning)
Activated M\&F volume before and after comprehensive treatment were evaluated by post-processing software
Change of M&F SUVmax and SUVmean
Time frame: Baseline, 1 day ( Contrast scanning)
SUVmax and SUVmean scores will be measured by post-processing software.
Change of anxiety symptoms
Time frame: Baseline, 1 day ( Contrast scanning)
Anxiety symptoms scores will be assessed with Hamilton Anxiety Scale.
Change of sleep
Time frame: Baseline, 1 day ( Contrast scanning)
Sleep scores will be assessed with Pittsburgh sleep quality index one month before scanning
Change of metabolism of glucose in the M&F
Time frame: Baseline, 1 day ( Contrast scanning)
Accumulation of 18F-FDG will be analyzed by treatment-related, psychology-related and intervention-related Positron emission tomography/ Magnetic resonance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuan Menghui, PHD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brown Fat and Muscle Metabolic and Differential Diagnosis, run by Tang-Du Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Yunbo, MD (15991771598, realmoco@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change metabolism of glucose of M&F (time frame: Baseline, 1 day ( Contrast scanning)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.