Breast Cancer
Conditions
Keywords
Breast cancer, Lumpectomy, Breast Irradiation
Brief 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.
Detailed description
Breast conserving therapy (BCT) has become the standard of care for treating early-stage breast cancers based on six prospective randomized trials with 20 years of follow-up data (Fisher). During lumpectomy, the surgeon removes the tumor and a surrounding rim of normal tissue (margin), leaving surgical clips to help designate the resection bed. Radiation treatment is directed at the whole breast for 5 1/2 weeks and is generally followed by a 1-2 week boost directed at the lumpectomy site plus a margin of normal breast tissue. The benefit of adding the tumor bed boost, (TBB) has been shown in two studies to decrease local failures \[Romestaig; Bartelink\]. Studies have evaluated the role of radiation following lumpectomy in very select groups which have not been able to define a group who do not benefit from the addition of radiotherapy. In the group of patients who received surgery alone, 85% of the breast recurrences occurred in the tumor bed. Due to these two facts, radiotherapy directed only at the tumor bed has been evaluated. Treating this smaller tumor volume has allowed higher doses of radiation to be delivered safely shortening the treatment course from 6-7 weeks to one week.
Interventions
None listed
Sponsors
University of Maryland, Baltimore
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breast Cup Immobilization Device II (GCC 1047) Feasibility | One year | 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
| Measure | Time frame | Description |
|---|---|---|
| Breast Cup Immobilization Device II (GCC 1047) Comfort | One year | 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). |
| Number of Participants That Were Favorable Candidates for Receiving GammaPod Treatment | 1 year | Candidates being assessed based on their breast size, tumor or tumor bed size, tumor or tumor bed location and normal tissue proximity by evaluating GammaPod treatment plans developed using the acquired CT images. Through images, patients were evaluated for their ability to meet the requirements for GammaPod treatment based off the factors mentioned previously. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Breastcup Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 4 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Breastcup |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 1 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Breast Cup Immobilization Device II (GCC 1047) Feasibility
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.
Time frame: One year
Population: Analysis was done through imaging assessment. Completed on all 25 patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Breastcup | Breast Cup Immobilization Device II (GCC 1047) Feasibility | 25 Participants |
Secondary
Breast Cup Immobilization Device II (GCC 1047) Comfort
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).
Time frame: One year
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Breastcup | Breast Cup Immobilization Device II (GCC 1047) Comfort | 0.6 score on a scale |
Secondary
Number of Participants That Were Favorable Candidates for Receiving GammaPod Treatment
Candidates being assessed based on their breast size, tumor or tumor bed size, tumor or tumor bed location and normal tissue proximity by evaluating GammaPod treatment plans developed using the acquired CT images. Through images, patients were evaluated for their ability to meet the requirements for GammaPod treatment based off the factors mentioned previously.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Breastcup | Number of Participants That Were Favorable Candidates for Receiving GammaPod Treatment | 25 Participants |