Stereotactic Body Radiation TherapyHYPNOCT-4DNCT07334990
Impact of a Hypnotic Recording on Artifacts in 4D CT in the Context of Stereotactic Body Radiation Therapy for Lung Cancer
A study testing Hypnotic record in people with Stereotactic Body Radiation Therapy and Lung Lesions, run by Centre Leon Berard.
Trial summary
This is a single-center prospective cohort study evaluating the impact of a simple audio recording hypnosis system on the occurrence of artifacts on 4D CT scans in patients requiring SBRT radiotherapy for lung lesions (peripheral or central). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stereotactic Body Radiation Therapy, Lung Lesions
- What is being tested?
- Hypnotic record
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2025to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years,
- Indication for lung SBRT, peripheral or central lesion,
- Patient new to hypnosis (medical or stage hypnosis),
- Patient covered by social security or equivalent,
- Dated and signed consent form.
Who cannot join
- Indication for treatment with abdominal compression,
- Patient undergoing treatment for multiple lesions in the same treatment sequence,
- Patient with an ultra-central lesion (distance to the mediastinum < 2 cm),
- Patient already included in this protocol,
- Cognitive or physical disorders preventing the trial from proceeding smoothly,
- Patient with one or more active psychotic disorders (such as schizophrenia),
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- Patients suffering from severe dissociative disorders,
- Patient who does not understand French or is deaf,
- Pregnant or breastfeeding women,
- Patient under guardianship or curatorship or deprived of liberty.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Séverine METZGER contact
About this study
This is a single-center prospective cohort study evaluating the impact of a simple audio recording hypnosis system on the occurrence of artifacts on 4D CT scans in patients requiring SBRT radiotherapy for lung lesions (peripheral or central).
The primary objective of the study is to evaluate the use of a hypnotic recording on the reduction of artifacts in 4D CT scans for patients undergoing stereotactic body radiation therapy for lung cancer.
Read more
The secondary objectives are to evaluate:
- the impact of hypnotic recording on the reduction of artifacts on intrathoracic structures (trachea, main bronchi, diaphragm, lesions, heart, and lungs),
- the regularity of respiratory amplitude,
- the regularity of respiratory rate,
- the volume of Internal Target Volume (ITV),
- the reproducibility of ITV volume,
- patient satisfaction.
- Before this dosimetric scan, the patient will complete a self-administered questionnaire on anxiety: the HADS-A questionnaire (Hospital Anxiety and Depression Scale-only questions relating to anxiety). During this examination, the MERM explains the dosimetric scan procedure to the patient. After the immobilization system has been set up in accordance with the department's standard protocol, a 4D CT scan will be performed while asking the patient to breathe regularly. In the event of an artifact at the level of the lesion, a second 4D CT scan will be performed under the same conditions.
- The hypnotic audio recording will be played through the room's speakers. The hypnotic recording is structured in three stages, with a 5-minute induction phase, a 5-minute working phase, and finally a 5-minute return phase. After 5 minutes of playback, the 4D CT scan for the study is performed using the same acquisition parameters as the free 4D CT scan.
- Following the first radiotherapy session and for all patients included in the study, a 4D dosimetric scan will be performed using the hypnotic recording again, as described above, in order to assess the inter-fraction reproducibility of the ITV volume.
Following this second 4D CT scan under hypnosis, patient satisfaction will be assessed (using a Likert scale questionnaire).
- Conditions
- Stereotactic Body Radiation Therapy, Lung Lesions
- Being tested
- Hypnotic record
- Keywords
- Hypnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnotic recordOther
The hypnotic audio recording will be played through the room's speakers. The hypnotic recording is structured in three stages, with a 5-minute induction phase, a 5-minute working phase, and finally a 5-minute return phase.
| Study group | Role | What they receive |
|---|---|---|
| Hypnotic record | Experimental | Not described Receives: Other: Hypnotic record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the proportion of 4D CT scans acquired under normal conditions and showing at least 1 artifact at the level of the lesion and the proportion of 4D CT scans acquired under hypnosis and showing >= 1artifact at the level of the lesion
Measured: Throught study completion, an average of 1 month
Secondary outcomes (6)
The proportion of 4D CT scans showing at least one artifact in lung volume for both acquisition conditions (with and without hypnotic recording)
Measured: Throught study completion, an average of 1 month
The difference between the minimum and maximum respiratory amplitude for the two acquisition conditions (with and without hypnotic recording);
Measured: Throught study completion, an average of 1 month
The difference between the minimum and maximum respiratory rate for the two acquisition conditions (with and without hypnotic recording);
Measured: Until the end of the study
The difference in ITV volume between the two acquisition conditions (with and without hypnotic recording)
Measured: Throught study completion, an average of 1 month
The difference in ITV size, in the craniocaudal axis, on 4D CT scans acquired under hypnotic recording
Measured: Throught study completion, an average of 1 month
The satisfaction questionnaire score (5-point Likert scales) following the second 4D CT scan under hypnosis.
Measured: Throught study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start30 Dec 2025 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stereotactic Body Radiation TherapyStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334990
- Sponsor's protocol ID
- ET25-084
- Acronym
- HYPNOCT-4D
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Hypnotic Recording on Artifacts in 4D CT in the Context of Stereotactic Body Radiation Therapy for Lung Cancer
- ClinicalTrials.gov ID
- NCT07334990
- Acronym / sponsor ID
- HYPNOCT-4D / ET25-084
- Conditions
- Stereotactic Body Radiation Therapy, Lung Lesions
- Keywords
- Hypnosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 12 Jan 2026 (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.
This is a single-center prospective cohort study evaluating the impact of a simple audio recording hypnosis system on the occurrence of artifacts on 4D CT scans in patients requiring SBRT radiotherapy for lung lesions (peripheral or central).
The primary objective of the study is to evaluate the use of a hypnotic recording on the reduction of artifacts in 4D CT scans for patients undergoing stereotactic body radiation therapy for lung cancer.
The secondary objectives are to evaluate:
- the impact of hypnotic recording on the reduction of artifacts on intrathoracic structures (trachea, main bronchi, diaphragm, lesions, heart, and lungs),
- the regularity of respiratory amplitude,
- the regularity of respiratory rate,
- the volume of Internal Target Volume (ITV),
- the reproducibility of ITV volume,
- patient satisfaction.
- Before this dosimetric scan, the patient will complete a self-administered questionnaire on anxiety: the HADS-A questionnaire (Hospital Anxiety and Depression Scale-only questions relating to anxiety). During this examination, the MERM explains the dosimetric scan procedure to the patient. After the immobilization system has been set up in accordance with the department's standard protocol, a 4D CT scan will be performed while asking the patient to breathe regularly. In the event of an artifact at the level of the lesion, a second 4D CT scan will be performed under the same conditions.
- The hypnotic audio recording will be played through the room's speakers. The hypnotic recording is structured in three stages, with a 5-minute induction phase, a 5-minute working phase, and finally a 5-minute return phase. After 5 minutes of playback, the 4D CT scan for the study is performed using the same acquisition parameters as the free 4D CT scan.
- Following the first radiotherapy session and for all patients included in the study, a 4D dosimetric scan will be performed using the hypnotic recording again, as described above, in order to assess the inter-fraction reproducibility of the ITV volume.
Following this second 4D CT scan under hypnosis, patient satisfaction will be assessed (using a Likert scale questionnaire).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypnotic record | Experimental | Other: Hypnotic record |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years,
- Indication for lung SBRT, peripheral or central lesion,
- Patient new to hypnosis (medical or stage hypnosis),
- Patient covered by social security or equivalent,
- Dated and signed consent form.
Key exclusion criteria (10 listed)
- Indication for treatment with abdominal compression,
- Patient undergoing treatment for multiple lesions in the same treatment sequence,
- Patient with an ultra-central lesion (distance to the mediastinum < 2 cm),
- Patient already included in this protocol,
- Cognitive or physical disorders preventing the trial from proceeding smoothly,
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 |
|---|---|---|
| Hypnotic recordThe hypnotic audio recording will be played through the room's speakers. The hypnotic recording is structured in three stages, with a 5-minute induction phase, a 5-minute working phase, and finally a 5-minute return phase. | Other | Hypnotic record |
Primary outcome
Difference between the proportion of 4D CT scans acquired under normal conditions and showing at least 1 artifact at the level of the lesion and the proportion of 4D CT scans acquired under hypnosis and showing >= 1artifact at the level of the lesion
Time frame: Throught study completion, an average of 1 month
6 secondary outcomes
The proportion of 4D CT scans showing at least one artifact in lung volume for both acquisition conditions (with and without hypnotic recording)
Time frame: Throught study completion, an average of 1 month
The difference between the minimum and maximum respiratory amplitude for the two acquisition conditions (with and without hypnotic recording);
Time frame: Throught study completion, an average of 1 month
The difference between the minimum and maximum respiratory rate for the two acquisition conditions (with and without hypnotic recording);
Time frame: Until the end of the study
The difference in ITV volume between the two acquisition conditions (with and without hypnotic recording)
Time frame: Throught study completion, an average of 1 month
The difference in ITV size, in the craniocaudal axis, on 4D CT scans acquired under hypnotic recording
Time frame: Throught study completion, an average of 1 month
The satisfaction questionnaire score (5-point Likert scales) following the second 4D CT scan under hypnosis.
Time frame: Throught study completion, an average of 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
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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.
Séverine METZGER contact
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotic record in people with Stereotactic Body Radiation Therapy and Lung Lesions, run by Centre Leon Berard.
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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 12 Jan 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Céline KERMORGANT (+33 4 78 78 28 28, celine.kermorgant@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between the proportion of 4D CT scans acquired under normal conditions and showing at least 1 artifact at the level of the lesion and the proportion of 4D CT scans acquired under hypnosis and showing >= 1artifact at the level of the lesion (time frame: Throught study completion, an average of 1 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 12 Jan 2026.