Tumor Monitoring Using Thermography During Radiation Therapy

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.

Study Overview

• Status: Unknown
• Conditions: Malignancy
• Intervention / Treatment: Other: Thermography imaging

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat-Gan, Israel
    • Recruiting
    • Merav Ben David

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients undergoing radiation; 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).	Other: Thermography imaging; Thermography imaging of the treated - irradiated body area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermal side effects during radiation therapy using CTCAE v4.0	Clinical assesment of the side effects by physician.	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.	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.

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Collaborators: Tel Aviv University

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): December 30, 2020

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: May 16, 2016
• First Posted (Estimate): May 19, 2016

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 7, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 1216-14-SMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO