Clinical trial · Observational
Breast Cup Immobilization Device II (GCC 1047)
Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II
- 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 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.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Breast Cup Immobilization Device II (GCC 1047) Feasibility
- timeFrame
- One year
- description
- Complete clinical feasibility of using a breast cup immobilization device for prone breast irradiation in terms of both geometric and dosimetric accuracy. Measurements were able to be completed on 25 participants through treatment planning CT scans.
Secondary outcomes (2)
- measure
- Breast Cup Immobilization Device II (GCC 1047) Comfort
- timeFrame
- One year
- description
- Assess patient comfort while wearing the breast cup immobilization device. Patients provided questionnaire to rate comfort level (discomfort was ranked from 0 (no pain) to 5 (very painful).
- measure
- Number of Participants That Were Favorable Candidates for Receiving GammaPod Treatment
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient must consent to be in the study and have signed an IRB-approved consent form. 2. The patient must have a diagnosis of invasive or non-invasive breast cancer. 3. 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. 6\. Patients who have already been treated by radiation therapy and are being seen in follow-up can also participate Exclusion Criteria: 1. Male gender 2. Patients who cannot be set up comfortably in the prone position (e.g. physical disability) 3. 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). 4. Mastectomy was or is the recommended surgical approach.
References
Publications (0)
Data not yet available