Tumor Monitoring Using Thermography During Radiation Therapy

NCT02776995 — Not applicable, Unknown, 80 participants, Sheba Medical Center

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Registry	NCT02776995
Status	Unknown
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, other
Enrollment	80 (Estimated)
Sponsor	Sheba Medical Center (Other gov); collaborators: Tel Aviv University
Conditions	Malignancy
Interventions	Thermography imaging (Other)
Dates	start 2014-11-01, primary completion 2020-12-30 (estimated), completion 2020-12-30 (estimated), first posted 2016-05-19, last updated 2019-04-09
Locations	1 site in Israel

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Patients undergoing radiation	Other	Other: 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).

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

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
Merav Ben David	Ramat Gan	Israel	Recruiting

+Investigators

Merav Ben-David, MD, Principal investigator, Sheba Medical Center