Tumor Monitoring Using Thermography During Radiation Therapy

• Sponsor: Sheba Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02776995
• Collaborator: Tel Aviv University (Other)
• Enrollment: 80
• Location: 1
• Arm: 1
• Duration (Months): 74
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignancy	Other: Thermography imaging	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Tumor Monitoring Using Thermography During Radiation Therapy
• Study Start Date: Nov 1, 2014
• Anticipated Primary Completion Date: Dec 30, 2020
• Anticipated Study Completion Date: Dec 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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 Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Merav Ben David	Ramat-Gan		Israel

Sponsors and Collaborators

• Sheba Medical Center
• Tel Aviv University

Investigators

• Principal Investigator: Merav Ben-David, MD, Sheba Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Merav Ben-David, Medical and Radiation Oncologist, Head of Breast Radioation Unit, Sheba Medical Center
• ClinicalTrials.gov Identifier: NCT02776995
• Other Study ID Numbers: 1216-14-SMC
• First Posted: May 19, 2016
• Last Update Posted: Apr 9, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Apr 9, 2019