Pilot Study to Validate Metallic Markers for Image Guided Radiation Therapy for Breast Cancer Tx
Pilot Study to Validate Metallic Markers for Image Guided Radiation Therapy for Breast Cancer Tx
The purpose of this study is to test metallic markers in the breast tissue after breast
 conserving surgery and to observe the metallic markers' stability in the breast for use as
 tumor bed markers and positioning devices for radiation treatment.
In order to validate metallic marker placement and stability, patients will have the internal
 metallic markers placed at the time of their last breast surgery (either lumpectomy or
 re-excision for margins) by the surgeon and are permanent. They will undergo routine 3D
 CT-based treatment planning and will receive routine radiation treatment to the whole breast
 or partial breast as determined by the treating physician. Daily images of the breast will be
 obtained throughout treatment using the online portal imaging system. These images will be
 analyzed for the daily position of the metallic markers and compared across the entire course
 of treatment to determine the stability of metallic markers placement and to assess their
 efficacy as positioning devices for image guided radiation therapy.
Inclusion Criteria:

 -  Pathologically confirmed stage 0, I or II bilateral or unilateral breast cancer

 -  Any invasive adenocarcinoma or intraductal carcinoma

 -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

 -  Surgical treatment with lumpectomy (partial mastectomy)

 -  Successful placement of intraparenchymal metallic markers at last breast surgery

 -  Pathologic tumor size < 5.0 cm (Microscopic multifocality is allowed if total
 pathologic tumor size is within 5 cm)

 -  Axillary sampling (sentinel node or axillary dissection) performed for axillary nodal
 staging for all invasive cancers. No axillary sampling is required for ductal
 carcinoma in situ)

 -  Negative margins of excision.

 -  Radiation treatment to begin within 8 weeks after last surgery or last dose of
 chemotherapy

 -  Negative post-biopsy mammogram if presented with mammographically detected
 microcalcifications to ensure removal of suspicious calcifications

 -  History of prior cancers is allowed if patient is without evidence of disease at the
 time of study entry

 -  Ability to understand and the willingness to sign written informed consent document

 Exclusion Criteria:

 -  Pregnant or breast feeding at time of study entry. Note: Radiation therapy is
 teratogenic. Women of child bearing potential must agree to use adequate contraception
 (abstinence, hormonal or barrier method of birth control) prior to and during study
 participation. Should a woman become pregnant, she should inform the treating
 physicians immediately.

 -  Prior in-field irradiation

 -  Stage III or IV breast cancer

 -  Inability to place intraparenchymal metallic markers due to excessive bleeding or
 other intraoperative complication so that the surgeon deems it inadvisable to place
 the marker

 -  Pathologic tumor size >/= 5 cm

 -  Positive or unassessed margins of surgical resection

 -  Diffuse calcifications on mammogram pre- or post-operatively

 -  Positive or suspicious post-lumpectomy mammogram or breast magnetic resonance imaging
 (MRI)

 -  Multicentric carcinoma in more than one quadrant of the breast

 -  Non-epithelial breast malignancy; Paget's disease of the nipple

 -  Personal history of collagen vascular disease clinically judged to be a
 contraindication to radiation therapy

 -  Recurrent disease or prior history of ipsilateral breast cancer

 -  Psychiatric or addictive disorders that impair patient's voluntary ability to
 participate in informed consent or protocol procedures