Monitoring HDR Brachytherapy for Cervical Cancer by Optic and Thermal Imaging

October 13, 2016 updated by: Dr. Tatiana Rabin MD, Sheba Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • signed informed consent
  • biopsy proven cervical cancer which will undergo definitive radiation

Exclusion Criteria:

  • not eligible to sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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 week during the brachytherapy treatment for 5 procedures
Radiation: THERMOGRAPHY IMAGING

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in Infra-Red radiation emitted at wavelengths 0.8-1nm
Time Frame: Baseline and 4 weeks
Measurement of IR
Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating of efficacy of the radiation
Time Frame: 3 months after the treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Anticipated)

July 1, 2017

Study Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (Estimate)

June 29, 2016

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 13, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-16-3171-RT-CTIL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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