Tumor Monitoring Using Thermography During Radiation Therapy

Not Applicable

• Conditions: Malignancy
• Interventions: Other: Thermography imaging

• Registration Number: NCT02776995
• Lead Sponsor: Sheba Medical Center

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.

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 Timeline

• Study Start: 2014-11
• Study First Submitted: 2016-05-10
• Study First Submitted QC: 2016-05-16
• Study First Posted: 2016-05-19
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-07
• Last Update Posted: 2019-04-09
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• signed informed consent
• will undergo radiation therapy for palliation or curative intent due to cancer, biopsy proven

Exclusion Criteria

• not eligible to sign informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients undergoing radiation	Thermography imaging	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).

Primary Outcome Measures

Name	Time	Method
Measurement of IR : Infra-Red radiation emitted at wavelengths 0.8-1nm	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

Secondary Outcome Measures

Name	Time	Method
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.	Clinical assesment of the side effects by physician.
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.	The tumor size will be measures to evaluate the efficacy of the radiation treatment.

Trial Locations

Locations (1)

Merav Ben David; 🇮🇱 Ramat-Gan, Israel