Pilot Study to Validate Metallic Markers for Image Guided Radiation Therapy for Breast Cancer Tx
January 29, 2013 updated by: H. Lee Moffitt Cancer Center and Research Institute
Pilot Study to Validate Metallic Markers for Image Guided Radiation Therapy for Breast Cancer Treatment
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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
61
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute, Inc.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Research subjects will be recruited from the clinical practice of the Breast Program referred for radiation therapy at Moffitt Cancer Center who meets the eligibility criteria.
This provides a potential pool of about 450 patients over a 12 month period.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Partial Breast Radiation
1. Patients receiving Partial breast radiation
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Non-contrast CT Scans prior to start of radiation therapy, and during weeks 2, 4, 6.
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Whole Breast Radiation
2. Patients receiving whole breast radiation
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Non-contrast CT Scans prior to start of radiation therapy and on Day 5.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Positional Stability of Metallic Markers in the Breast Parenchyma
Time Frame: Completion of planned radiation treatment.
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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.
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Completion of planned radiation treatment.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Eleanor Harris, M.D., H. Lee Moffitt Cancer Center and Research Institute, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
December 4, 2008
First Submitted That Met QC Criteria
December 4, 2008
First Posted (Estimate)
December 5, 2008
Study Record Updates
Last Update Posted (Estimate)
January 30, 2013
Last Update Submitted That Met QC Criteria
January 29, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCC-15303
- 106406 (Other Identifier: USF IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.