Monitoring HDR Brachytherapy for Cervical Cancer by Optic and Thermal Imaging

• Sponsor: Sheba Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02818179
• Collaborator: (none)
• Enrollment: 100
• Arm: 1
• Duration (Months): 7

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 radiation therapy in treated organ will be evaluated.

Condition or Disease	Intervention/Treatment	Phase
MALIGNANCY	Radiation: THERMOGRAPHY IMAGING	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Monitoring HDR Brachytherapy for Cervical Cancer by Optic and Thermal Imaging
• Study Start Date: Dec 1, 2016
• Anticipated Primary Completion Date: Jul 1, 2017
• Anticipated Study Completion Date: Jul 1, 2017

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

Outcome Measures

Primary Outcome Measures

1. The change in Infra-Red radiation emitted at wavelengths 0.8-1nm [Baseline and 4 weeks]

   Measurement of IR

Secondary Outcome Measures

1. Evaluating of efficacy of the radiation [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• signed informed consent

• biopsy proven cervical cancer which will undergo definitive radiation

Exclusion Criteria:

• not eligible to sign informed consent

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Sheba Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Tatiana Rabin MD, Senior Medical Doctor, Sheba Medical Center
• ClinicalTrials.gov Identifier: NCT02818179
• Other Study ID Numbers: SHEBA-16-3171-RT-CTIL
• First Posted: Jun 29, 2016
• Last Update Posted: Oct 14, 2016
• Last Verified: Oct 1, 2016

• Additional relevant MeSH terms: Uterine Cervical Neoplasms

Study Results

No Results Posted as of Oct 14, 2016