Lung CancerNCT00508313
Thermal Signature of Patients Undergoing Radiation Therapy
An observational study of Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Thermal Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Feb 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with lung cancer and healthy participants without cancer.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Phase I Assessment of Thermal Signature of Patients Undergoing Radiation Therapy
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Thermal Imaging
- Keywords
- Lung Cancer, Healthy Control, Thermal Imaging, Thermal Signatures, Radiation Therapy, Chemoradiation Therapy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal ImagingProcedure or surgery
Thermal imaging sessions, each taking approximately 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| With Lung Cancer | Patients with lung cancer. Receives: Procedure: Thermal Imaging | |
| Healthy Participants | Healthy participants without cancer. Receives: Procedure: Thermal Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: Baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: Study closed early without enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhongxing Liao, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508313
- Sponsor's protocol ID
- 2006-1082
- Status last verified
- Sep 2009
- First submitted
- 26 Jul 2007
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Assessment of Thermal Signature of Patients Undergoing Radiation Therapy
- ClinicalTrials.gov ID
- NCT00508313
- Acronym / sponsor ID
- 2006-1082
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Healthy Control, Thermal Imaging, Thermal Signatures, Radiation Therapy, Chemoradiation Therapy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study closed early without enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 27 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Lung Cancer | – | Procedure: Thermal ImagingPatients with lung cancer. |
| Healthy Participants | – | Procedure: Thermal ImagingHealthy participants without cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lung cancer and healthy participants without cancer.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal ImagingThermal imaging sessions, each taking approximately 10 minutes. | Procedure or surgery | Healthy Participants, With Lung Cancer |
Primary outcome
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
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.
1 secondary outcome
Number Toxicities Experienced by Participants according to CTCAE v. 3.0
Time frame: Baseline to 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2016.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhongxing Liao, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2016.