NCT01517581

Brief Summary

White and brown adipocytes differ in their expression of hormones, cytokines, and inflammatory factors, and they modulate different biological functions. While white adipose tissue (WAT) serves as the primary site of energy storage, brown adipose tissue (BAT) instead metabolizes fat to produce heat and regulate body temperature. BAT is likely present in all humans, but the low prevalence of BAT depiction in adults and elderly subjects has hindered longitudinal assessments of the relation between BAT activity and WAT. Under typical imaging conditions, BAT is detected more frequently in children and teenagers than in adults with malignancy. Since most children with cancer have significantly shorter treatment courses and greater survival rates compared to adult patients, the investigators have the ability to examine the relation of repeated measures of body composition and BAT by selecting pediatric patients. In this study, the investigators will longitudinally examine whether BAT activity is related to changes in weight and the amounts of SAT, VAT, and abdominal muscle in children successfully treated for pediatric cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
Last Updated

January 25, 2012

Status Verified

January 1, 2012

Enrollment Period

2.9 years

First QC Date

January 20, 2012

Last Update Submit

January 24, 2012

Conditions

Keywords

Brown adipose tissue

Outcome Measures

Primary Outcomes (4)

  • Change from Baseline in Subcutaneous Adipose Tissue Volume at Follow-up

    Baseline and up to 1 year

  • Change from Baseline in Visceral Adipose Tissue Volume at Follow-up

    Baseline and up to 1 year

  • Change from Baseline in Presence of Brown Adipose Tissue

    Baseline and up to 1 year

  • Change from Baseline in Abdominal Musculature Volume

    Baseline and up to 1 year

Secondary Outcomes (1)

  • Change from Baseline in Anthropometric Measures at Follow-up

    Baseline and up to 1 year

Study Arms (1)

Malignant Disease with no visualized BAT

Children 18 years or younger who 1) had PET/CT scans with evidence of malignant disease but no metabolically active brown adipose tissue (BAT) at diagnosis and 2) were disease free within 1 year of diagnosis.

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric patients with a history of malignancy such that they are required to undergo PET/CT exams.

You may qualify if:

  • Patients had PET/CT scans with evidence of malignant disease
  • Patients had no metabolically active BAT at diagnosis on their PET/CT scan
  • Patients were disease free within 1 year of diagnosis

You may not qualify if:

  • Patients had PET/CT scans with no evidence of malignant disease
  • Patients with metabolically active BAT at diagnosis on their PET/CT scan
  • Patients were not disease free within 1 year of diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027-6062, United States

Location

Related Publications (6)

  • Hamilton G, Smith DL Jr, Bydder M, Nayak KS, Hu HH. MR properties of brown and white adipose tissues. J Magn Reson Imaging. 2011 Aug;34(2):468-73. doi: 10.1002/jmri.22623.

    PMID: 21780237BACKGROUND
  • Gilsanz V, Chung SA, Jackson H, Dorey FJ, Hu HH. Functional brown adipose tissue is related to muscle volume in children and adolescents. J Pediatr. 2011 May;158(5):722-6. doi: 10.1016/j.jpeds.2010.11.020. Epub 2010 Dec 18.

  • Gilsanz V, Smith ML, Goodarzian F, Kim M, Wren TA, Hu HH. Changes in brown adipose tissue in boys and girls during childhood and puberty. J Pediatr. 2012 Apr;160(4):604-609.e1. doi: 10.1016/j.jpeds.2011.09.035. Epub 2011 Nov 1.

  • Gilsanz V, Chung SA, Kaplowitz N. Differential effect of gender on hepatic fat. Pediatr Radiol. 2011 Sep;41(9):1146-53. doi: 10.1007/s00247-011-2021-7. Epub 2011 Mar 15.

  • Hu HH, Chung SA, Nayak KS, Jackson HA, Gilsanz V. Differential computed tomographic attenuation of metabolically active and inactive adipose tissues: preliminary findings. J Comput Assist Tomogr. 2011 Jan-Feb;35(1):65-71. doi: 10.1097/RCT.0b013e3181fc2150.

  • Chalfant JS, Smith ML, Hu HH, Dorey FJ, Goodarzian F, Fu CH, Gilsanz V. Inverse association between brown adipose tissue activation and white adipose tissue accumulation in successfully treated pediatric malignancy. Am J Clin Nutr. 2012 May;95(5):1144-9. doi: 10.3945/ajcn.111.030650. Epub 2012 Mar 28.

MeSH Terms

Conditions

Hodgkin DiseaseLymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Vicente Gilsanz, MD, PhD

    Children's Hospital Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 20, 2012

First Posted

January 25, 2012

Study Start

October 1, 2008

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

January 25, 2012

Record last verified: 2012-01

Locations