Expired Study
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Tampa, Florida 33612


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

MCC-15303


NCT ID:

NCT00802932


Secondary ID:

106406


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

H. Lee Moffitt Cancer Center and Research Institute


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: P


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

61


Enrollment Type:

Actual


Overall Contact Information

Official Name:Eleanor Harris, M.D.
Principal Investigator
H. Lee Moffitt Cancer Center and Research Institute, Inc.

Study Dates

Start Date:March 2008
Completion Date:October 2012
Completion Type:Actual
Primary Completion Date:October 2012
Primary Completion Type:Actual
Verification Date:January 2013
Last Changed Date:January 29, 2013
First Received Date:December 4, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Positional Stability of Metallic Markers in the Breast Parenchyma
Time Frame:Completion of planned radiation treatment.
Safety Issues:False
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 t

Study Interventions

Intervention Type:Device
Name:Non-contrast Computed Tomography (CT) Scans (Metal
Description:Non-contrast CT Scans prior to start of radiation therapy, and during weeks 2, 4, 6.
Arm Name:Partial Breast Radiation
Intervention Type:Device
Name:Non-contrast CT Scans (Metallic Markers)
Description:Non-contrast CT Scans prior to start of radiation therapy and on Day 5.
Arm Name:Whole Breast Radiation

Study Arms

Study Arm Type:Other
Arm Name:Partial Breast Radiation
Description:1. Patients receiving Partial breast radiation
Study Arm Type:Other
Arm Name:Whole Breast Radiation
Description:2. Patients receiving whole breast radiation

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:H. Lee Moffitt Cancer Center and Research Institute

Samples and Retentions

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.
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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