MALIGNANCYNCT02818179
Monitoring HDR Brachytherapy for Cervical Cancer by Optic and Thermal Imaging
A study testing THERMOGRAPHY IMAGING in people with MALIGNANCY, run by Sheba Medical Center.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- MALIGNANCY
- What is being tested?
- THERMOGRAPHY IMAGING
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- signed informed consent
- biopsy proven cervical cancer which will undergo definitive radiation
Who cannot join
- not eligible to sign informed consent
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- MALIGNANCY
- Being tested
- THERMOGRAPHY IMAGING
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THERMOGRAPHY IMAGINGRadiation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: THERMOGRAPHY IMAGING |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Infra-Red radiation emitted at wavelengths 0.8-1nm
Measurement of IR
Measured: Baseline and 4 weeks
Secondary outcomes (1)
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
Measured: 3 months after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startDec 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MALIGNANCYStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Tatiana Rabin MD, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818179
- Sponsor's protocol ID
- SHEBA-16-3171-RT-CTIL
- Status last verified
- Oct 2016
- First submitted
- 16 Jun 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring HDR Brachytherapy for Cervical Cancer by Optic and Thermal Imaging
- ClinicalTrials.gov ID
- NCT02818179
- Acronym / sponsor ID
- SHEBA-16-3171-RT-CTIL
- Conditions
- MALIGNANCY
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Dec 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 29 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing radiation | Other | Radiation: THERMOGRAPHY IMAGINGIn 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- signed informed consent
- biopsy proven cervical cancer which will undergo definitive radiation
Key exclusion criteria (1 listed)
- not eligible to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| THERMOGRAPHY IMAGING | Radiation | Patients undergoing radiation |
Primary outcome
The change in Infra-Red radiation emitted at wavelengths 0.8-1nm
Time frame: Baseline and 4 weeks
Measurement of IR
1 secondary outcome
Evaluating of efficacy of the radiation
Time frame: 3 months after the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing THERMOGRAPHY IMAGING in people with MALIGNANCY, run by Sheba Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tatiana Rabin, MD (972- ext. 5305085, tatiana.rabin@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in Infra-Red radiation emitted at wavelengths 0.8-1nm (time frame: Baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2016.