Clinical trial · Observational
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 Treatment
NCT00802932CI-TRIAL-00009190completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-contrast Computed Tomography (CT) Scans (Metallic Markers) | Device | — | UNRESOLVED |
| Non-contrast CT Scans (Metallic Markers) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Partial Breast Radiation
- description
- 1\. Patients receiving Partial breast radiation
- interventionNames
- Device: Non-contrast Computed Tomography (CT) Scans (Metallic Markers)
- label
- Whole Breast Radiation
- description
- 2\. Patients receiving whole breast radiation
- interventionNames
- Device: Non-contrast CT Scans (Metallic Markers)
Primary outcomes (1)
- measure
- Positional Stability of Metallic Markers in the Breast Parenchyma
- timeFrame
- Completion of planned radiation treatment.
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.