Thermal Signature of Patients Undergoing Radiation Therapy

NCT00508313 | Withdrawn

• 1 other identifier: 2006-1082
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

Lung Cancer; Healthy Control; Thermal Imaging; Thermal Signatures; Radiation Therapy; Chemoradiation Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Participant Thermal Signature as determined by Thermal imaging (recording body temperature)

  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.

  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

Secondary Outcomes (1)

• Number Toxicities Experienced by Participants according to CTCAE v. 3.0

  Baseline to 24 months

Study Arms (2)

With Lung Cancer

Patients with lung cancer.

Procedure: Thermal Imaging

Healthy Participants

Healthy participants without cancer.

Procedure: Thermal Imaging

Interventions

Thermal Imaging PROCEDURE

Thermal imaging sessions, each taking approximately 10 minutes.

Healthy Participants; With Lung Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with lung cancer and healthy participants without cancer.

You may qualify if:

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

You may not qualify if:

• Patients who had lung surgery within past 3 months.
• Patients with breast implant or cardiac implant (pace maker or defibrillator).
• Patients who had skin diseases (e.g. skin desquamation, dermatitis) or other medical conditions that may interfere with thermal measurement.
• Pregnant woman
• Extreme obese patients with body mass index \>=35

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zhongxing Liao, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2007
• First Posted: July 27, 2007
• Study Start: July 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: April 8, 2016

Record last verified: 2009-09

Locations

US (1)