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NCT02818179 Clinical Trial

Monitoring HDR Brachytherapy for Cervical Cancer by Optic and Thermal Imaging

MALIGNANCY Clinical Trial

Official title:
Monitoring HDR Brachytherapy for Cervical Cancer by Optic and Thermal Imaging

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02818179
Other study ID # SHEBA-16-3171-RT-CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received June 16, 2016
Last updated October 13, 2016
Start date December 2016
Est. completion date July 2017

Study information
Verified date October 2016
Source Sheba Medical Center
Contact Tatiana Rabin, MD
Phone 972-
Email tatiana.rabin@sheba.health.gov.il
Is FDA regulated No
Health authority Israel: Ethics Commission
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 radiation therapy in treated organ will be evaluated.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- signed informed consent

- biopsy proven cervical cancer which will undergo definitive radiation

Exclusion Criteria:

- not eligible to sign informed consent

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Radiation:
• THERMOGRAPHY IMAGING

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Outcome
Type Measure Description Time frame Safety issue
Primary The change in Infra-Red radiation emitted at wavelengths 0.8-1nm Measurement of IR Baseline and 4 weeks No
Secondary Evaluating of efficacy of the radiation The thermal and the optic imaging will be taken and analyzed in order to evaluate the changing in the temperature of the cervix comparing to the baseline as the indication of the response to the radiotherapy 3 months after the treatment No
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