N/A
N=25
Breast Cup Immobilization Device II (GCC 1047)
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01704547 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Breast Cup Immobilization Device II (GCC 1047) Feasibility — 25 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Breast Cup Immobilization Device II (GCC 1047) Feasibility |
25 | — |
| SECONDARY Breast Cup Immobilization Device II (GCC 1047) Comfort |
0.6 | — |
| SECONDARY Number of Participants That Were Favorable Candidates for Receiving GammaPod Treatment |
25 | — |
Summary
The study is designed to assess the accuracy of patient breast reproducibly using the revised BCID. This study would provide data for target verification and quality assurance to eventually allow treatment of breast cancer patients for either a TBB or accelerated partial breast irradiation. The BCID is a low-risk device similar to immobilization devices used routinely in radiotherapy for other disease sites.
Eligibility Criteria
Inclusion Criteria
- The patient must consent to be in the study and have signed an IRB-approved consent form.
- The patient must have a diagnosis of invasive or non-invasive breast cancer.
- The patient must be planned for or have already had breast conservation surgery (i.e. lumpectomy).
4 Age > 18. 5. There are at least two metal clips in the surgical cavity placed at the time of surgery for guiding the radiation oncologist in delineating the target of irradiation; or one radiographic clip placed at the time of stereotactic core needle biopsy with the intact tumor.
- Patients who have already been treated by radiation therapy and are being seen in follow-up can also participate
Exclusion Criteria
- Male gender
- Patients who cannot be set up comfortably in the prone position (e.g. physical disability)
- Tumor/lumpectomy site located in a portion of the breast that cannot be visualized easily on the CT scan (e.g. superior portion of the upper outer quadrant).
- Mastectomy was or is the recommended surgical approach.
Data sourced from ClinicalTrials.gov (NCT01704547). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.