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Breast Cup Immobilization Device II (GCC 1047) (BCID II)

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ClinicalTrials.gov Identifier: NCT01704547
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : June 21, 2017
Sponsor:
Information provided by (Responsible Party):
Department of Radiation Oncology, University of Maryland, College Park

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.

Condition or disease
Breast Cancer

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.


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Study Type : Observational
Actual Enrollment : 25 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II
Study Start Date : October 2012
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Breast Cup Immobilization Device II (GCC 1047) [ Time Frame: One year ]
    Assess the clinical feasibility,of using a breast cup immobilization device for prone breast irradiation in terms of both geometric and dosimetric accuracy


Secondary Outcome Measures :
  1. Breast Cup Immobilization Device II (GCC 1047) [ Time Frame: One year ]
    1.Assess patient comfort while wearing the breast cup immobilization device and evaluate mock treatment plans for patients using the acquired CT images.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cancer Center, Primary Care Clinic
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704547


Locations
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United States, Maryland
Ummc Msgcc
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, College Park
Investigators
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Principal Investigator: Elizabeth Nichols, MD University of Maryland, College Park

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Responsible Party: Department of Radiation Oncology, Principal Investigator, University of Maryland, College Park
ClinicalTrials.gov Identifier: NCT01704547     History of Changes
Other Study ID Numbers: HP-00047123
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: June 21, 2017
Last Verified: June 2017
Keywords provided by Department of Radiation Oncology, University of Maryland, College Park:
Breast cancer
Lumpectomy
Breast Irradiation
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases