Thermal Signature of Patients Undergoing Radiation Therapy

This study has been withdrawn prior to enrollment.
(Study closed early without enrollment.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00508313
First received: July 26, 2007
Last updated: April 6, 2016
Last verified: September 2009
  Purpose

The goal of this clinical research study is to evaluate whether thermal imaging (recording body temperature) can be used to check the body's response to cancer therapy.

Primary Objective:

  • The primary objective of this study is to establish techniques and methodologies of quantifying thermal signatures and their changes for cancer patients undergoing chemoradiation therapy.

Secondary Objective:

  • The secondary objective is to evaluate correspondence between changes of thermal signature of a normal organ, e.g. lung or esophagus, versus the toxicity of that organ from chemoradiation therapy.

Condition Intervention
Lung Cancer
Procedure: Thermal Imaging

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Phase I Assessment of Thermal Signature of Patients Undergoing Radiation Therapy

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Change in Participant Thermal Signature as determined by Thermal imaging (recording body temperature) [ Time Frame: Imaging session takes about 10 minutes to complete each time, imaging beginning at baseline and continuing till 12 months post therapy, up to 24 months ] [ Designated as safety issue: No ]
    Body temperature at the time of the thermal imaging taken using a commercial infrared camera; thermal imaging sessions several times before the cancer treatment starts, during and after the radiotherapy courses. Using thermal images taken from multiple sessions, both the absolute and relative changes of the temperature distribution will be calculated and analyzed. The location of the regions will be guided by the diagnostic computed tomography (CT) and Positron Emission Positron emission tomography (PET)/CT images for temperatures at multiple angles of body, site of radiation for skin reaction, primary cancer site and critical normal organs.


Secondary Outcome Measures:
  • Number Toxicities Experienced by Participants according to CTCAE v. 3.0 [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
    Chemoradiation related toxicity, including hematological and nonhematological acute and late side effects assessed during each clinic visit and follow up session including patient clinical symptoms and clinical assessment of treatment-related toxicity as assessed by NCI Common Terminology Criteria for Adverse Events version 3.0 (CTCAE).


Enrollment: 0
Study Start Date: July 2007
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
With Lung Cancer
Patients with lung cancer.
Procedure: Thermal Imaging
Thermal imaging sessions, each taking approximately 10 minutes.
Healthy Participants
Healthy participants without cancer.
Procedure: Thermal Imaging
Thermal imaging sessions, each taking approximately 10 minutes.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with lung cancer and healthy participants without cancer.
Criteria

Inclusion Criteria:

  1. Patients with lung cancers of any stages.
  2. Patients will undergo chemotherapy or radiation therapy.
  3. Patients with KPS > 70, are physically mobile and independent, and are able to stand still straight for more than 10 minutes for imaging purposes.
  4. Age >18 years

Exclusion Criteria:

  1. Patients who had lung surgery within past 3 months.
  2. Patients with breast implant or cardiac implant (pace maker or defibrillator).
  3. Patients who had skin diseases (e.g. skin desquamation, dermatitis) or other medical conditions that may interfere with thermal measurement.
  4. Pregnant woman
  5. Extreme obese patients with body mass index >=35
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508313

Locations
United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Zhongxing Liao, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00508313     History of Changes
Other Study ID Numbers: 2006-1082 
Study First Received: July 26, 2007
Last Updated: April 6, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Lung Cancer
Healthy Control
Thermal Imaging
Thermal Signatures
Radiation Therapy
Chemoradiation Therapy

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 21, 2016