Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00508313
Status:
WITHDRAWN
Last Update Posted:
2016-04-08
First Post:
2007-07-26
Brief Title:
Thermal Signature of Patients Undergoing Radiation Therapy
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Assessment of Thermal Signature of Patients Undergoing Radiation Therapy
Status:
WITHDRAWN
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study closed early without enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to evaluate whether thermal imaging recording body temperature can be used to check the bodys 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 eg lung or esophagus versus the toxicity of that organ from chemoradiation 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 eg lung or esophagus versus the toxicity of that organ from chemoradiation therapy
Detailed Description:
For Patients
THERMAL IMAGER
A thermal imager a camera similar to a digital camera takes pictures of skin surfaces The imager is able to view temperature distribution of the skin surface
STUDY PARTICIPATION
If you agree to take part in this study your body temperature will be measured with thermal imaging
You will have thermal imaging sessions several times before the cancer treatment starts and during the therapy course You will be given detailed instructions on how to prepare for the imaging sessions ahead of time as well as what to expect during the imaging sessions
Before beginning thermal imaging your temperature will be measured with a thermometer To perform thermal imaging you will be asked to take off all of your clothes in a private room and stand still in front of a thermal imaging camera No one will be present while you disrobe When you have finished taking off your clothes a radiation oncologist or other medical doctor will record several pictures from a computer stationed outside the room Pictures of your front back and side views will be taken These pictures will look like a silhouette body outline with thermal coloring The entire imaging session should take about 10 minutes to complete each time
LENGTH OF STUDY
Your participation will be over in this study after the thermal images have been recorded
This is an investigational study Thermal imaging is FDA approved and commercially available for breast cancer screening Its use in this study is investigational Up to 35 patients will take part in this study All will be enrolled at M D Anderson
For Volunteers
THERMAL IMAGER
A thermal imager a camera similar to a digital camera takes pictures of skin surfaces The imager is able to view temperature distribution of the skin surface
STUDY PARTICIPATION
If you agree to take part in this study your body temperature will be measured with thermal imaging
You will have thermal imaging sessions several times during the course of this study You will be given detailed instructions on how to prepare for the imaging sessions ahead of time as well as what to expect during the imaging sessions
Before beginning thermal imaging your temperature will be measured with a thermometer To perform thermal imaging you will be asked to take off all of your clothes in a private room and stand still in front of a thermal imaging camera No one will be present while you disrobe When you have finished taking off your clothes a radiation oncologist or other medical doctor will record several pictures from a computer stationed outside the room Pictures of your front back and side views will be taken These pictures will look like a silhouette body outline with thermal coloring The entire imaging session should take about 10 minutes to complete each time
Volunteers will not participate in any part of cancer treatment diagnostic imaging tests CT PET etc or any other clinical procedures in MD Anderson Volunteers will not need to see physicians at MD Anderson or elsewhere Thermal images will be taken 4 times during one day for a volunteer morning midmorning earlier afternoon late afternoon Volunteers should not take any medications or perform any other medical procedures from morning to late afternoon until the thermal imaging is completed
LENGTH OF STUDY
Your participation will be over in this study after the thermal images have been recorded
This is an investigational study Thermal imaging is FDA approved and commercially available for breast cancer screening Its use in this study is investigational Up to 10 volunteers without cancer 5 males and 5 non-pregnant females will take part in this study All will be enrolled at M D Anderson
THERMAL IMAGER
A thermal imager a camera similar to a digital camera takes pictures of skin surfaces The imager is able to view temperature distribution of the skin surface
STUDY PARTICIPATION
If you agree to take part in this study your body temperature will be measured with thermal imaging
You will have thermal imaging sessions several times before the cancer treatment starts and during the therapy course You will be given detailed instructions on how to prepare for the imaging sessions ahead of time as well as what to expect during the imaging sessions
Before beginning thermal imaging your temperature will be measured with a thermometer To perform thermal imaging you will be asked to take off all of your clothes in a private room and stand still in front of a thermal imaging camera No one will be present while you disrobe When you have finished taking off your clothes a radiation oncologist or other medical doctor will record several pictures from a computer stationed outside the room Pictures of your front back and side views will be taken These pictures will look like a silhouette body outline with thermal coloring The entire imaging session should take about 10 minutes to complete each time
LENGTH OF STUDY
Your participation will be over in this study after the thermal images have been recorded
This is an investigational study Thermal imaging is FDA approved and commercially available for breast cancer screening Its use in this study is investigational Up to 35 patients will take part in this study All will be enrolled at M D Anderson
For Volunteers
THERMAL IMAGER
A thermal imager a camera similar to a digital camera takes pictures of skin surfaces The imager is able to view temperature distribution of the skin surface
STUDY PARTICIPATION
If you agree to take part in this study your body temperature will be measured with thermal imaging
You will have thermal imaging sessions several times during the course of this study You will be given detailed instructions on how to prepare for the imaging sessions ahead of time as well as what to expect during the imaging sessions
Before beginning thermal imaging your temperature will be measured with a thermometer To perform thermal imaging you will be asked to take off all of your clothes in a private room and stand still in front of a thermal imaging camera No one will be present while you disrobe When you have finished taking off your clothes a radiation oncologist or other medical doctor will record several pictures from a computer stationed outside the room Pictures of your front back and side views will be taken These pictures will look like a silhouette body outline with thermal coloring The entire imaging session should take about 10 minutes to complete each time
Volunteers will not participate in any part of cancer treatment diagnostic imaging tests CT PET etc or any other clinical procedures in MD Anderson Volunteers will not need to see physicians at MD Anderson or elsewhere Thermal images will be taken 4 times during one day for a volunteer morning midmorning earlier afternoon late afternoon Volunteers should not take any medications or perform any other medical procedures from morning to late afternoon until the thermal imaging is completed
LENGTH OF STUDY
Your participation will be over in this study after the thermal images have been recorded
This is an investigational study Thermal imaging is FDA approved and commercially available for breast cancer screening Its use in this study is investigational Up to 10 volunteers without cancer 5 males and 5 non-pregnant females will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None