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Brown adipose tissue activity in lung cancer

Conditions
Wasting
Weight loss
10003018
10027655
10029107
Registration Number
NL-OMON37755
Lead Sponsor
Medisch Universitair Ziekenhuis Maastricht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
13
Inclusion Criteria

Resectable non-small cell lung cancer (NSCLC)
Age 40-70 years
Gender: male and female
Caucasians
Non-obese persons, i.e. Body Mass Index (BMI) <30 kg/m2

Exclusion Criteria

Primary
• Body Mass Index > 30 kg/m2
• Medically treated Diabetes mellitus (oral anti-diabetics, insulin)
• Severe COPD and/or heart failure
• Patients with severe clotting disorder
• Patients with a second malignancy, either active or in previous medical history
• Thyroid disorders
• Psychological unstable persons presumed unfit to perform the measurements, including claustrophobia
• Patients with shortness of breath in rest
• Persons unable to lie or sit still for1-2 hours
• Pregnant subjects
• Subjects that received high doses of radiotherapeutic radiation of the neck and/or upper chest in their medical history
• Persons that received cervical of thoracic sympathectomy or have a nerve dysfunction which is likely to influence sympathetic nerves
• The use of the medication that influences the sympathetic nerve system: ß-blockers, a-blockers, central anti-hypertensives, certain anti-depression drugs (MAO inhibitors, tricyclic anti-depressives) reserpine, cocaïne, calciumblockers, labetalol, certain tranquillizers (fenothiazines)
• Exclusion criteria for core temperature measurement:
-In any patient whose body weight is less than 40 kg
-In the presence of any known or suspected obstructive disease of the gastrointestinal tract
-In any patient exhibiting or having a history of disorders or impairment of the gag reflex
-In any patient with previous gastrointestinal surgery
-In any patient having structural and/or functional disorders of the esophagus
-In any patient who might undergo Nuclear Magnetic Resonance (NMR) or MRI scanning during the period that the CorTemp* Disposable Temperature Sensor is within the body.
-In any patient with hypo motility disorders of the gastrointestinal tract
-In any patient having a cardiac pacemaker or other implanted electro medical device.;Secondary
• Unsuccesful complete macro- and microscopic resection of the lung tumor
• Presence of tumor recurrence on the second PET-CT scan

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>BAT volume and intensity in kBq/SUV in the presence (before operation) compared<br /><br>to absense (after operation) of lung cancer, as determined by 18 F-FDG PET-CT<br /><br>scanning.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Second primary endpoint are the effects on energy expenditure, body core<br /><br>temperature, skin surface temperature, body composition and serum leverls of<br /><br>CRP and selected hormones that influence BAT activity</p><br>
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