MalignancyNCT02776995
Tumor Monitoring Using Thermography During Radiation Therapy
A study testing Thermography imaging in people with Malignancy, run by Sheba Medical Center at 1 site in Israel.
Trial summary
This research aims to investigate the correlation between tumor temperature difference and biological factors, such as size, metabolism, treatment response, and tumor aggressiveness. In addition, normal tissue response to adjuvant radiation therapy in treated organs following surgery, will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignancy
- What is being tested?
- Thermography imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2014to 30 Dec 2020
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signed informed consent
- will undergo radiation therapy for palliation or curative intent due to cancer, biopsy proven
Who cannot join
- not eligible to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
This research aims to investigate the correlation between tumor temperature difference and biological factors, such as size, metabolism, treatment response, and tumor aggressiveness.
In addition, normal tissue response to adjuvant radiation therapy in treated organs following surgery, will be evaluated.
Read the detailed description
During radiation session, the investigators would evaluate the changes that will be detected by thermal imaging and correlate them with visible side effects as well as with known tumor biology factors and skin-tumor distance.
- Conditions
- Malignancy
- Being tested
- Thermography imaging
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermography imagingOther
Thermography imaging of the treated - irradiated body area.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing radiation | Other | In this study, patients undergoing radiation treatment will undergo thermography imaging during radiation treatment course. Patients will be evaluated with thermography imaging every 5 fraction of radiation, starting prior to the first radiation treatment, periodically, until the end of radiation therapy (a period of several weeks). Receives: Other: Thermography imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of IR : Infra-Red radiation emitted at wavelengths 0.8-1nm
Mathematical analysis of the thermic image
Measured: Before the first fraction of radiation and every 5 fraction until the end of radiation therapy, approximately 4-5 weeks.
Secondary outcomes (2)
Dermal side effects during radiation therapy using CTCAE v4.0
Clinical assesment of the side effects by physician.
Measured: Before the first fraction of radiation and every 5 fraction until the end of radiation therapy, approximately 4-5 weeks.
US/CT scans
The tumor size will be measures to evaluate the efficacy of the radiation treatment.
Measured: The tumor size in cubic cm will be mesured prior to first fraction of radiation, and 2 weeks following the end of radiation session. Time for final evaluation: approximately 6-7 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startNov 2014
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalignancyStudies of the same condition, open and under way.
- More trials run by Sheba Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Tel Aviv University
- Responsible party
- Principal investigator, Dr. Merav Ben-David, Sheba Medical Center
- Investigators
- Merav Ben-David, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776995
- Sponsor's protocol ID
- 1216-14-SMC
- Status last verified
- Apr 2019
- First submitted
- 10 May 2016
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Monitoring Using Thermography During Radiation Therapy
- ClinicalTrials.gov ID
- NCT02776995
- Acronym / sponsor ID
- 1216-14-SMC
- Conditions
- Malignancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Tel Aviv University
- Study start
- Nov 2014
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 19 May 2016 (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.
This research aims to investigate the correlation between tumor temperature difference and biological factors, such as size, metabolism, treatment response, and tumor aggressiveness.
In addition, normal tissue response to adjuvant radiation therapy in treated organs following surgery, will be evaluated.
Detailed description
During radiation session, the investigators would evaluate the changes that will be detected by thermal imaging and correlate them with visible side effects as well as with known tumor biology factors and skin-tumor distance.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing radiation | Other | Other: Thermography imagingIn this study, patients undergoing radiation treatment will undergo thermography imaging during radiation treatment course. Patients will be evaluated with thermography imaging every 5 fraction of radiation, starting prior to the first radiation treatment, periodically, until the end of radiation therapy (a period of several weeks). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- signed informed consent
- will undergo radiation therapy for palliation or curative intent due to cancer, biopsy proven
Key exclusion criteria (1 listed)
- not eligible to sign informed consent
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 |
|---|---|---|
| Thermography imagingThermography imaging of the treated - irradiated body area. | Other | Patients undergoing radiation |
Primary outcome
Measurement of IR : Infra-Red radiation emitted at wavelengths 0.8-1nm
Time frame: Before the first fraction of radiation and every 5 fraction until the end of radiation therapy, approximately 4-5 weeks.
Mathematical analysis of the thermic image
2 secondary outcomes
Dermal side effects during radiation therapy using CTCAE v4.0
Time frame: Before the first fraction of radiation and every 5 fraction until the end of radiation therapy, approximately 4-5 weeks.
US/CT scans
Time frame: The tumor size in cubic cm will be mesured prior to first fraction of radiation, and 2 weeks following the end of radiation session. Time for final evaluation: approximately 6-7 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Merav Ben-David, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermography imaging in people with Malignancy, run by Sheba Medical Center at 1 site in Israel.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Apr 2019. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merav Ben-David, MD (972-3-5305086, merav.ben-david@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of IR : Infra-Red radiation emitted at wavelengths 0.8-1nm (time frame: Before the first fraction of radiation and every 5 fraction until the end of radiation therapy, approximately 4-5 weeks.). 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 9 Apr 2019.