To study the effect of early tumour development on brown adipose tissue activity
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
- Miscellaneous and site unspecified neoplasms malignant and unspecified
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
BAT volume and intensity in kBq/SUV in the presence (before operation) compared
to absense (after operation) of lung cancer, as determined by 18 F-FDG PET-CT
scanning.
Secondary outcome
Second primary endpoint are the effects on energy expenditure, body core
temperature, skin surface temperature, body composition and serum leverls of
CRP and selected hormones that influence BAT activity
Background summary
Evidence by rodent studies in tomour models with cachexia have shovn an
association between significant weight loss and significant degree of BAT
thermogenic activation, providing evidence of BAT activation in tumour-bearing
mice with cachexia. Activity of brown adipose tissue (BAT)in adult humans has
only recently been discovered by the introduction of 18F-FDG PET-CT. Moreover,
white dispose cells can directly transdifferentiate into brown adipose cells,
the so-called BRITE cell recruitment. The observation of BAT in oncology
patient staging by 18F-FDG PET-CT scanning as well asthe strong correlation
between BAT activity and body mass index (BMI) has prompted the revisit of a
possible role of BAT activation in human patients cancer cachexia. W
hypothesize that an abnormal thermogenic activity exists in cancer patients
through the inappropriate stimulation by the hypothalamas and BAT activity that
normalizes after complete resection of the tumour
Study objective
To study the effect of early tumour development on brown adipose tissue
activity
Study design
Determine BAT activity iin cancer by use of PET-Imaging in a prospective study
design
Study burden and risks
The Absorbed radiation dose of the FDG-PET-CT scan technique (administration
of 74 MBq of 18F-FGD, total-body scan) is 3,7 mSv per scan (ICRP 103,
berekening met computer programma CT-Expo versie 2.0). Subjects will be scanned
twice, which is considered as a low risk. The subcutaneous fat biopsy is a
minimally invasive procedure producing little discomfort
P.Debyelaan 185
Maastricht 6202 AZ
NL
P.Debyelaan 185
Maastricht 6202 AZ
NL
Listed location countries
Age
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, α-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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39941.068.12 |
| Other | Volgt bij goedkeuring |