Irradiation; Adverse EffectICSINCT05966363
Comparison of Cone Beam Irradiation Versus Multi-detector Scanner for Ear Imaging
An observational study of Irradiation; Adverse Effect, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The primary objective of this study is to compare the irradiation between Cone Beam and CT of the petrous bone. The primary endpoint is the measurement of equivalent doses per organ of interest (eyes, ears, thyroid and external genitalia). The investigators have set up a prospective monocentric study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Irradiation; Adverse Effect
- What is being tested?
- Nanodot
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jul 2023to 19 Sep 2024
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients are recruited during a consultation in the ENT department, either as part of a pre-cochlear implant assessment, or as part of a prescription for a CT scan of the petrous bone by the Besançon University Hospital ENT department department to be carried out at Besançon University Hospital.
Who may be able to join
- Adult or child patients of any gender and any age, including the pediatric population, receiving a CT scan of the petrous bone performed at Besançon University Hospital and prescribed in the Besançon University Hospital ENT department, or receiving a CBCT as part of an intraoperative check of cochlear implant position.
- Women menopausal for at least 24 months, surgically sterilized, or, for women of childbearing age, using an effective contraceptive method (oral contraceptives, contraceptive injections, intra-uterine devices, double-barrier method, contraceptive patches).
- Subject's non-opposition to study participation
- Affiliation with a French social security scheme or beneficiary of such a scheme.
Who cannot join
- Legal incapacity or limited legal capacity
- Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of this study is to compare the irradiation between Cone Beam and CT of the petrous bone.
The primary endpoint is the measurement of equivalent doses per organ of interest (eyes, ears, thyroid and external genitalia).
The investigators have set up a prospective monocentric study. The investigators will measure irradiation of these different organs using nanodots placed on the patient during imaging.
The results of these measurements will be compared between Cone Beam (performed in the Besançon University Hospital ENT department for cochlear implant position checks) and CT (all indications combined).
- Conditions
- Irradiation; Adverse Effect
- Being tested
- Nanodot
- Keywords
- irradiation, TDM, Cone Beam, CT, CBCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanodotRadiation
Radiation measurements using nanodots placed on the eyes, ears, neck and lower abdomen during an imaging examination.
| Study group | Role | What they receive |
|---|---|---|
| CBCT | Patients receiving a Cone Beam of the rocks as part of a cochlear implant position check at Besançon University Hospital Receives: Radiation: Nanodot | |
| CT | Patients receiving a CT scan of the rocks at Besançon University Hospital, all indications combined Receives: Radiation: Nanodot |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT and CBCT induced Irradiation in ear imaging in adults with adult protocol
To compare CT and CBCT induced irradiation in ear imaging in adults and children > 15 years of age who have benefited from an adult protocol.
Measured: 9 month
Secondary outcomes (2)
CT and CBCT induced Irradiation in ear imaging in children with Pediatric protocol
To compare CT and CBCT induced irradiation in ear imaging in children ≤ 15 years of age who have benefited from a pediatric protocol.
Measured: 9 month
CT and CBCT induced Irradiation in ear imaging in adults with pediatric protocol
To compare CT and CBCT induced irradiation in ear imaging in adults and children > 15 years of age who have benefited from a pediatric protocol.
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start26 Jul 2023
- Primary completion19 Sep 2024
- Study completion19 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irradiation; Adverse EffectStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966363
- Sponsor's protocol ID
- 2023/738
- Acronym
- ICSI
- Status last verified
- Sep 2024
- First submitted
- 30 Jun 2023
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cone Beam Irradiation Versus Multi-detector Scanner for Ear Imaging
- ClinicalTrials.gov ID
- NCT05966363
- Acronym / sponsor ID
- ICSI / 2023/738
- Conditions
- Irradiation; Adverse Effect
- Keywords
- irradiation, TDM, Cone Beam, CT, CBCT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 19 Sep 2024 (actual)
- Study completion
- 19 Sep 2024 (actual)
- First posted
- 28 Jul 2023 (actual)
- 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.
The primary objective of this study is to compare the irradiation between Cone Beam and CT of the petrous bone.
The primary endpoint is the measurement of equivalent doses per organ of interest (eyes, ears, thyroid and external genitalia).
The investigators have set up a prospective monocentric study. The investigators will measure irradiation of these different organs using nanodots placed on the patient during imaging.
The results of these measurements will be compared between Cone Beam (performed in the Besançon University Hospital ENT department for cochlear implant position checks) and CT (all indications combined).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBCT | – | Radiation: NanodotPatients receiving a Cone Beam of the rocks as part of a cochlear implant position check at Besançon University Hospital |
| CT | – | Radiation: NanodotPatients receiving a CT scan of the rocks at Besançon University Hospital, all indications combined |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients are recruited during a consultation in the ENT department, either as part of a pre-cochlear implant assessment, or as part of a prescription for a CT scan of the petrous bone by the Besançon University Hospital ENT department department to be carried out at Besançon University Hospital.
Key inclusion criteria (4 listed)
- Adult or child patients of any gender and any age, including the pediatric population, receiving a CT scan of the petrous bone performed at Besançon University Hospital and prescribed in the Besançon University Hospital ENT department, or receiving a CBCT as part of an intraoperative check of cochlear implant position.
- Women menopausal for at least 24 months, surgically sterilized, or, for women of childbearing age, using an effective contraceptive method (oral contraceptives, contraceptive injections, intra-uterine devices, double-barrier method, contraceptive patches).
- Subject's non-opposition to study participation
- Affiliation with a French social security scheme or beneficiary of such a scheme.
Key exclusion criteria (2 listed)
- Legal incapacity or limited legal capacity
- Subject unlikely to cooperate with the study and/or poor cooperation anticipated by the investigator.
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 |
|---|---|---|
| NanodotRadiation measurements using nanodots placed on the eyes, ears, neck and lower abdomen during an imaging examination. | Radiation | CBCT, CT |
Primary outcome
CT and CBCT induced Irradiation in ear imaging in adults with adult protocol
Time frame: 9 month
To compare CT and CBCT induced irradiation in ear imaging in adults and children > 15 years of age who have benefited from an adult protocol.
2 secondary outcomes
CT and CBCT induced Irradiation in ear imaging in children with Pediatric protocol
Time frame: 9 month
CT and CBCT induced Irradiation in ear imaging in adults with pediatric protocol
Time frame: 9 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irradiation; Adverse Effect, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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 2 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: finished, as of the sponsor's last update on 23 Sep 2024. 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 France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CT and CBCT induced Irradiation in ear imaging in adults with adult protocol (time frame: 9 month). 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 23 Sep 2024.