An interventional study of Radiation Therapy (RT) in Breast Cancer, sponsored by NYU Langone Health. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-17.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Supportive care
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.
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
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 40 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Radiation: Radiation Therapy (RT)
Undergo RT either in the supine position with DIBH or in the prone position.
Also known as: Cancer Radiotherapy, Radiotherapy, RT
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.
Time frame: Up to 6 weeks
Volume of heart receiving > 20 gray (Gy)
The volume of heart receiving \>20Gy in DIBH plan vs. prone plan
Time frame: 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
Time frame: 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
Time frame: Up to 6 weeks
Mean ipsilateral lung dose
The mean ipsilateral lung dose in DIBH plan vs. prone plan
Time frame: Up to 6 weeks
Volume of ipsilateral lung receiving > 20Gy
The volume of ipsilateral lung receiving \>20Gy in DIBH plan vs. prone plan
Time frame: 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
Time frame: 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
Time frame: Up to 6 weeks
Maximum separation
The maximum separation in DIBH plan vs. prone plan
Time frame: 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
Time frame: Up to 6 weeks
PTV breast volume as calculated on the prone scan
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)
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
Time frame: 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.
Time frame: Up to 6 weeks
No study locations are listed for this record.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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