Breast CancerBCID IINCT01704547
Breast Cup Immobilization Device II (GCC 1047)
An observational study of Breast Cancer, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Mar 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Cancer Center, Primary Care Clinic
Who may be able to join
- 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.
- 6. Patients who have already been treated by radiation therapy and are being seen in follow-up can also participate
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II
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.
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Lumpectomy, Breast Irradiation
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Secondary outcomes (2)
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).
Measured: One year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Department of Radiation Oncology, University of Maryland, Baltimore
- Investigators
- Elizabeth Nichols, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704547
- Sponsor's protocol ID
- HP-00047123
- Acronym
- BCID II
- Status last verified
- May 2022
- First submitted
- 28 Sep 2012
- Last updated
- 1 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II
- ClinicalTrials.gov ID
- NCT01704547
- Acronym / sponsor ID
- BCID II / HP-00047123
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Lumpectomy, Breast Irradiation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Oct 2012 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Oct 2012 (estimated)
- Results
- Posted 1 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer Center, Primary Care Clinic
Key inclusion criteria (5 listed)
- 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.
- 6. Patients who have already been treated by radiation therapy and are being seen in follow-up can also participate
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Breast Cup Immobilization Device II (GCC 1047) Feasibility
Time frame: 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.
2 secondary outcomes
Breast Cup Immobilization Device II (GCC 1047) Comfort
Time frame: One year
Number of Participants That Were Favorable Candidates for Receiving GammaPod Treatment
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Nichols, MD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast Cup Immobilization Device II (GCC 1047) Feasibility (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.