Registry Study of the Contura™ Multi-Lumen Balloon (MLB) Applicator for Accelerated Partial Breast Irradiation in Intermediate-Risk, Pathological Stage 0, I, or II (Up to 3.0 cm) Breast Cancer Patients
In approximately 20% of patients who are considered for accelerated partial breast
irradiation (APBI), the balloon-to-skin distance ranges from 3-6 mm. The Contura applicator
has 5 source lumens. In contrast, the MammoSite catheter has a single source lumen. The
ability to choose from multiple source lumens with the Contura catheter allows one to avoid
a radiation "hot spot" in the skin in cases where the balloon-to-skin spacing is only 3-6
mm.
Another limitation of the MammoSite catheter is that one cannot improve on the suboptimal
conformance of the balloon with the surrounding breast tissue. An air/fluid pocket next to
the balloon can push breast tissue at greatest risk of harboring residual disease away from
the radioactive source. With APBI, the planning target volume for plan evaluation
(PTV_EVAL) is defined as the breast tissue volume bounded by uniform expansion of the
balloon radius in all dimensions by 10 mm less the balloon volume. PTV_EVAL is limited to 5
mm from the skin surface and by the posterior breast tissue extent (chest wall and
pectoralis muscles are excluded). The volume of an air/fluid pocket is usually 4.8% ± 1.1%
(mean ± standard error) of PTV_EVAL. The Contura applicator has a vacuum lumen with 2
openings adjacent to the balloon that allow for air/fluid removal. By using the vacuum
lumen on a Contura applicator, one can typically decrease the size of an air/fluid pocket by
about one third. In approximately 90% of Contura patients, the volume of an air/fluid
pocket around the balloon can be reduced to less than or equal to 3.0% of PTV_EVAL. In
contrast, the volume of an air/fluid pocket around the balloon is less than or equal to 3.0%
of PTV_EVAL in only about half of MammoSite patients. Since this study addresses
intermediate-risk patients, it is particularly important that the size of an air/fluid
pocket be minimized with a Contura applicator.
SenoRx, Inc. (Aliso Viejo, CA) is currently conducting a registry study of the Contura MLB
applicator in the "low-risk" patient population. This "intermediate-risk" study is
complimentary to the low-risk registry study. There is no overlap in patient eligibility.
Intermediate-risk patients meet any of the following criteria:
1. Age 18-49 years, or
2. Estrogen receptor-negative and progesterone receptor-negative breast cancer, or
3. 1-3 involved axillary lymph nodes
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum skin dose is less than or equal to 100% of the prescribed radiation dose and air/fluid pocket next to the balloon is less than or equal to 3.0% of the planning target volume for plan evaluation
19 months
Yes
Richard B Wilder, MD
Principal Investigator
Cancer Center of Irvine
United States: Institutional Review Board
1098987
NCT00882089
October 2007
December 2009
Name | Location |
---|---|
Cancer Center of Irvine | Irvine, California 92618 |