NCT02818179

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

7 months

First QC Date

June 16, 2016

Last Update Submit

October 13, 2016

Conditions

MALIGNANCY

Outcome Measures

Primary Outcomes (1)

  • The change in Infra-Red radiation emitted at wavelengths 0.8-1nm

    Measurement of IR

    Baseline and 4 weeks

Secondary Outcomes (1)

  • Evaluating of efficacy of the radiation

    3 months after the treatment

Study Arms (1)

Patients undergoing radiation

OTHER

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

Interventions

THERMOGRAPHY IMAGINGRADIATION
Patients undergoing radiation

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • not eligible to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Interventions

Thermography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisThermometryInvestigative Techniques

Central Study Contacts

Tatiana Rabin, MD

CONTACT

972-tatiana.rabin@sheba.health.gov.il

Zvi Symon, MD

CONTACT

972zvi.symon@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Medical Doctor

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 29, 2016

Study Start

December 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

October 14, 2016

Record last verified: 2016-10