Tumor Monitoring Using Thermography During Radiation Therapy

Malignancy Clinical Trial

Official title:

Tumor Monitoring Using Thermography During Radiation Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02776995
• Other study ID #: 1216-14-SMC
• Status: Recruiting
• Phase: N/A
• Start date: November 2014
• Est. completion date: December 30, 2020

Study information

• Verified date: April 2019
• Source: Sheba Medical Center
• Contact: Merav Ben-David, MD
• Phone: 972-3-5305086
• Email: merav.ben-david[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignancy

Intervention

Other:
• Thermography imaging
Thermography imaging of the treated - irradiated body area.

Locations

Country	Name	City	State
Israel	Merav Ben David	Ramat-Gan

Sponsors (2)

Lead Sponsor	Collaborator
Sheba Medical Center	Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.