Tumor Monitoring Using Thermography During Radiation Therapy
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 10, 2016
CompletedFirst Posted
Study publicly available on registry
May 19, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedApril 9, 2019
April 1, 2019
6.2 years
May 10, 2016
April 7, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Measurement of IR : Infra-Red radiation emitted at wavelengths 0.8-1nm
Mathematical analysis of the thermic image
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
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 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.
Study Arms (1)
Patients undergoing radiation
OTHERIn 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).
Interventions
Thermography imaging of the treated - irradiated body area.
Eligibility Criteria
You may qualify if:
- signed informed consent
- will undergo radiation therapy for palliation or curative intent due to cancer, biopsy proven
You may not qualify if:
- not eligible to sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sheba Medical Centerlead
- Tel Aviv Universitycollaborator
Study Sites (1)
Merav Ben David
Ramat Gan, Israel
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Merav Ben-David, MD
Sheba Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical and Radiation Oncologist, Head of Breast Radioation Unit
Study Record Dates
First Submitted
May 10, 2016
First Posted
May 19, 2016
Study Start
November 1, 2014
Primary Completion
December 30, 2020
Study Completion
December 30, 2020
Last Updated
April 9, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share