Breast CancerNCT03437161
A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation
A study testing Radiation Therapy (RT) in people with Breast Cancer, run by NYU Langone Health.
Trial summary
This phase II trial studies how well deep inspiratory breath hold or prone breast radiation therapy works in reducing cardiac dose in patients with breast cancer or ductal carcinoma in situ. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radiation Therapy (RT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 17 Jan 2017to 15 Feb 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any woman with biopsy proven left breast DCIS or invasive cancer who has undergone a lumpectomy and who requires whole breast irradiation to the breast alone (and not to any nodal regions) as per the treating radiation oncologist
Who cannot join
- Previous radiation to the ipsilateral breast
- All pre-menopausal women will require a urine qualitative pregnancy test to exclude pregnancy; pregnant women will be excluded from the study
About this study
This phase II trial studies how well deep inspiratory breath hold or prone breast radiation therapy works in reducing cardiac dose in patients with breast cancer or ductal carcinoma in situ. Deep inspiratory breath hold is a technique that involves a patient holding their breath during radiation to move the heart away from the breast to minimize radiation to the heart. Prone breast radiation therapy is a technique in which a patient receives treatment "face-down" to minimize the radiation to the rest of the body, including the heart and lungs. Comparing deep inspiratory breath hold to prone breast radiation therapy may help doctors improve radiation to the target while reducing radiation to healthy tissues surrounding the target.
Read the detailed description
Patients attend a simulation visit and undergo two CT scans, one in the prone position and one in the supine position with DIBH. Within 1 week after the simulation visit, patients undergo radiation therapy either in the supine position with DIBH or in the prone position daily for 15-30 consecutive days as per physician's prescription
- Conditions
- Breast Cancer
- Being tested
- Radiation Therapy (RT)
- Keywords
- Radiation, Prone position, Supine position, DIBH, Invasive Breast Carcinoma, Ductal Breast Carcinoma In Situ
- Medical subject headings
- Breast Neoplasms, Deception, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation Therapy (RT)Radiation
Also called Cancer Radiotherapy, Radiotherapy, RT
Undergo RT either in the supine position with DIBH or in the prone position.
| Study group | Role | What they receive |
|---|---|---|
| Radiation Therapy (RT) | Experimental | Patients attend a simulation visit and undergo two CT scans, one in the prone position and one in the supine position with DIBH. Within 1 week after the simulation visit, patients undergo radiation therapy either in the supine position with DIBH or in the prone position daily for 15-30 consecutive days as per physician's prescription. Receives: Radiation: Radiation Therapy (RT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean cardiac dose
Assess whether the mean cardiac dose in the supine DIBH plan differs from the mean cardiac dose in the prone plan within strata defined by total RT dose.
Measured: Up to 6 weeks
Secondary outcomes (12)
Volume of heart receiving > 20 gray (Gy)
The volume of heart receiving >20Gy in DIBH plan vs. prone plan
Measured: Up to 6 weeks
Mean left anterior descending artery (LAD) dose in DIBH plan vs. prone plan
The mean LAD dose in DIBH plan vs. prone plan
Measured: Up to 6 weeks
Maximum left anterior descending artery (LAD) dose in DIBH plan vs. prone plan
The maximum LAD dose in DIBH plan vs. prone plan
Measured: Up to 6 weeks
Mean ipsilateral lung dose
The mean ipsilateral lung dose in DIBH plan vs. prone plan
Measured: Up to 6 weeks
Volume of ipsilateral lung receiving > 20Gy
The volume of ipsilateral lung receiving >20Gy in DIBH plan vs. prone plan
Measured: Up to 6 weeks
Volume of the contralateral breast receiving > 5 Gy
The volume of the contralateral breast receiving >5Gy in DIBH plan vs. prone plan
Measured: Up to 6 weeks
Maximum point dose to planning target volume (PTV) breast
The maximum point dose to PTV breast in DIBH plan vs. prone plan
Measured: Up to 6 weeks
Maximum separation
The maximum separation in DIBH plan vs. prone plan
Measured: Up to 6 weeks
Distance from the mid-sternum to the nipple when the patient is in the prone position
Distance from the mid-sternum to the nipple when the patient is in the prone position
Measured: Up to 6 weeks
PTV breast volume as calculated on the prone scan
PTV breast volume as calculated on the prone scan
Measured: Up to 6 weeks
Change in distance between the chest wall and heart (at the most lateral portion of the chest-wall-heart interface)
The change in distance between the chest wall and heart (at the most lateral portion of the chestwall-heart interface) between the free breathing scout films and the DIBH scout films
Measured: Up to 6 weeks
Patient treatment plan (supine with DIBH or prone)
Will be described by proportions and frequency distributions. Logistic regression will be used to assess how each of the covariates (primary and secondary endpoints) affects the probability of being selected to undergo RT using the supine DIBH plan. ROC curves will be generated for various cut-points of the true proportion of patients requiring the supine DIBH plan.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start17 Jan 2017
- Primary completion26 Sep 2017
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naamit Gerber, MD, Principal investigator, Laura and Isaac Perlmutter Cancer Center at NYU Langone
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03437161
- Sponsor's protocol ID
- 16-01477
- Other IDs
- s16-01477
- Status last verified
- Feb 2023
- First submitted
- 5 Feb 2018
- Last updated
- 17 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial to Compare Deep Inspiratory Breath Hold (DIBH) With Prone Breast Irradiation
- ClinicalTrials.gov ID
- NCT03437161
- Acronym / sponsor ID
- 16-01477
- Conditions
- Breast Cancer
- Keywords
- Radiation, Prone position, Supine position, DIBH, Invasive Breast Carcinoma, Ductal Breast Carcinoma In Situ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 26 Sep 2017 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 19 Feb 2018 (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 phase II trial studies how well deep inspiratory breath hold or prone breast radiation therapy works in reducing cardiac dose in patients with breast cancer or ductal carcinoma in situ. Deep inspiratory breath hold is a technique that involves a patient holding their breath during radiation to move the heart away from the breast to minimize radiation to the heart. Prone breast radiation therapy is a technique in which a patient receives treatment "face-down" to minimize the radiation to the rest of the body, including the heart and lungs. Comparing deep inspiratory breath hold to prone breast radiation therapy may help doctors improve radiation to the target while reducing radiation to healthy tissues surrounding the target.
Detailed description
Patients attend a simulation visit and undergo two CT scans, one in the prone position and one in the supine position with DIBH. Within 1 week after the simulation visit, patients undergo radiation therapy either in the supine position with DIBH or in the prone position daily for 15-30 consecutive days as per physician's prescription
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiation Therapy (RT) | Experimental | Radiation: Radiation Therapy (RT)Patients attend a simulation visit and undergo two CT scans, one in the prone position and one in the supine position with DIBH. Within 1 week after the simulation visit, patients undergo radiation therapy either in the supine position with DIBH or in the prone position daily for 15-30 consecutive days as per physician's prescription. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any woman with biopsy proven left breast DCIS or invasive cancer who has undergone a lumpectomy and who requires whole breast irradiation to the breast alone (and not to any nodal regions) as per the treating radiation oncologist
Key exclusion criteria (2 listed)
- Previous radiation to the ipsilateral breast
- All pre-menopausal women will require a urine qualitative pregnancy test to exclude pregnancy; pregnant women will be excluded from the study
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 |
|---|---|---|
| Radiation Therapy (RT)Also: Cancer Radiotherapy, Radiotherapy, RTUndergo RT either in the supine position with DIBH or in the prone position. | Radiation | Radiation Therapy (RT) |
Primary outcome
Mean cardiac dose
Time frame: Up to 6 weeks
Assess whether the mean cardiac dose in the supine DIBH plan differs from the mean cardiac dose in the prone plan within strata defined by total RT dose.
12 secondary outcomes
Volume of heart receiving > 20 gray (Gy)
Time frame: Up to 6 weeks
Mean left anterior descending artery (LAD) dose in DIBH plan vs. prone plan
Time frame: Up to 6 weeks
Maximum left anterior descending artery (LAD) dose in DIBH plan vs. prone plan
Time frame: Up to 6 weeks
Mean ipsilateral lung dose
Time frame: Up to 6 weeks
Volume of ipsilateral lung receiving > 20Gy
Time frame: Up to 6 weeks
Volume of the contralateral breast receiving > 5 Gy
Time frame: Up to 6 weeks
Maximum point dose to planning target volume (PTV) breast
Time frame: Up to 6 weeks
Maximum separation
Time frame: Up to 6 weeks
Distance from the mid-sternum to the nipple when the patient is in the prone position
Time frame: Up to 6 weeks
PTV breast volume as calculated on the prone scan
Time frame: Up to 6 weeks
Change in distance between the chest wall and heart (at the most lateral portion of the chest-wall-heart interface)
Time frame: Up to 6 weeks
Patient treatment plan (supine with DIBH or prone)
Time frame: Up to 6 weeks
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 17 Feb 2023.
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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.
Naamit Gerber, MD principal investigator
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Questions about this trial
What is this clinical trial studying?
A study testing Radiation Therapy (RT) in people with Breast Cancer, run by NYU Langone Health.
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 1 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 17 Feb 2023. 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?
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?
Mean cardiac dose (time frame: Up to 6 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 17 Feb 2023.