Cervical NeoplasiaPhase 1/2NCT02908607
Thermal Imaging for Evaluation of the Cervix
A Phase 1/2 study testing Thermal imaging in people with Cervical Neoplasia, run by Meir Medical Center at 1 site in Israel.
Trial summary
When screening results for cervical premalignant lesions are positive, colposcopy is recommended. This is highly sensitive screening method. However, specificity of the test is of low. Thus, a technology that improves the accuracy of the colposcopic exam is needed. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Neoplasia
- What is being tested?
- Thermal imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2016to Mar 2019
- Phase
- Phase 1/2
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18
- Women with premalignant cervical lesions who are candidates for conization (group A)
- Women with a normal cervix who are candidates for hysterectomy (group B)
- Women with newly diagnosed cervical cancer
Who cannot join
- For group A and B - women that had conization in the past
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thermal Imaging for Cervical Cancer Screening and Early Detection
When screening results for cervical premalignant lesions are positive, colposcopy is recommended. This is highly sensitive screening method. However, specificity of the test is of low.
Thus, a technology that improves the accuracy of the colposcopic exam is needed.
This is a feasibility study with the goal of examining the performance of a thermal imaging camera in the detection of cervical malignant and premalignant lesions.
- Conditions
- Cervical Neoplasia
- Being tested
- Thermal imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal imagingDevice
Examination of the cervix by thermal imaging camera
| Study group | Role | What they receive |
|---|---|---|
| experimental | Experimental | 3 groups of patients will be participated: women with cancer, women with premalignant lesions and women with a normal cervix. All patients will undergo the same examination Receives: Device: Thermal imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of identification of premalignant and malignant lesions of the cervix by thermal imaging
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical NeoplasiaStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yfat kadan, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02908607
- Sponsor's protocol ID
- 0104-16-MMC
- Status last verified
- Sep 2016
- First submitted
- 18 Sep 2016
- Last updated
- 21 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermal Imaging for Cervical Cancer Screening and Early Detection
- ClinicalTrials.gov ID
- NCT02908607
- Acronym / sponsor ID
- 0104-16-MMC
- Conditions
- Cervical Neoplasia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Mar 2019 (estimated)
- First posted
- 21 Sep 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.
When screening results for cervical premalignant lesions are positive, colposcopy is recommended. This is highly sensitive screening method. However, specificity of the test is of low.
Thus, a technology that improves the accuracy of the colposcopic exam is needed.
This is a feasibility study with the goal of examining the performance of a thermal imaging camera in the detection of cervical malignant and premalignant lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental | Experimental | Device: Thermal imaging3 groups of patients will be participated: women with cancer, women with premalignant lesions and women with a normal cervix. All patients will undergo the same examination |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18
- Women with premalignant cervical lesions who are candidates for conization (group A)
- Women with a normal cervix who are candidates for hysterectomy (group B)
- Women with newly diagnosed cervical cancer
Key exclusion criteria (1 listed)
- For group A and B - women that had conization in the past
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 |
|---|---|---|
| Thermal imagingExamination of the cervix by thermal imaging camera | Device | experimental |
Primary outcome
The rate of identification of premalignant and malignant lesions of the cervix by thermal imaging
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Thermal imaging in people with Cervical Neoplasia, run by Meir Medical Center at 1 site in Israel.
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 4 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 21 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yfat Kadan, Dr (972-9-7471575, yfat_ka@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of identification of premalignant and malignant lesions of the cervix by thermal imaging (time frame: 2 years). 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 21 Sep 2016.