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Pilot Study to Validate Metallic Markers for Image Guided Radiation Therapy for Breast Cancer Treatment

18 Years
Not Enrolling
Breast Cancer

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Trial Information

Pilot Study to Validate Metallic Markers for Image Guided Radiation Therapy for Breast Cancer 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

- 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

- 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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Positional Stability of Metallic Markers in the Breast Parenchyma

Outcome Description:

To validate that intraparenchymal metallic markers placed in the breast tissue can be used as stable markers throughout a course of radiation treatment for daily image guided localization. Image Guided Radiation Therapy (IGRT) will be deemed feasible if the average shift in marker position results in deviations of up to 7 mm from the initial position.

Outcome Time Frame:

Completion of planned radiation treatment.

Safety Issue:


Principal Investigator

Eleanor Harris, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute, Inc.


United States: Institutional Review Board

Study ID:




Start Date:

March 2008

Completion Date:

October 2012

Related Keywords:

  • Breast Cancer
  • breast cancer
  • female
  • metallic markers
  • image guided radiation therapy
  • IGRT
  • Breast Neoplasms



H. Lee Moffitt Cancer Center and Research Institute, Inc.Tampa, Florida  33612