RECRUITING

GammaPod Dose Escalation Radiation for Early Stage Breast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The GammaPod machine was made by Xcision Medical Systems and is already FDA cleared to deliver focused radiation within the breast. Unlike current radiation machines, the GammaPod was designed specifically for treating breast cancer. The GammaPod can pinpoint radiation to the tumor bed in the breast which lowers the amount of radiation to nearby tissues. The machine uses a breast cup system to hold the breast in place for the treatment. This breast cup system was tested at MSGCCC (Marlene Stewart Greenebaum Comprehensive Cancer Center). Patients reported this system was more comfortable than an MRI or mammogram. The cup system was able to securely position the breast for treatment in the correct location. Receiving radiation before surgery is not a new concept in cancer management. Preoperative radiation has proven to result in improved disease free survival in certain types of cancer. With this study treatment, the participants will receive a dose of breast radiation therapy before the lumpectomy surgery. The lumpectomy surgery is where they remove the participant's tumor. The purpose of this research study is to determine a safe and effective dose of pre-operative radiation to treat early stage breast cancer. The pre-operative radiation is delivered using the FDA approved, GammaPod machine. The study will also determine the cosmesis of pre-operative radiation at different doses. Cosmesis is another word for looking at skin changes. The research team will use questionnaires for patient and physicians to assess adverse cosmesis changes as accurately as possible. In addition, the investigators are going to assess radiation related changes using photo software analysis tools and patients quality of life.

Official Title

GCC 1926- Phase Ib Dose Escalation of Single-Fraction Preoperative Stereotactic Partial-Breast Irradiation for Early-Stage Breast Cancer

Quick Facts

Study Start:2021-09-15

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04234386

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients must sign consent for study participation. * Patients must be female with a diagnosis of invasive ductal carcinoma. Lobular histologies will not be included, because of difficulty in defining the extent of disease with imaging. * Patients must be deemed appropriate candidates for breast-conserving therapy (i.e., not pregnant, never had RT to the treated breast, breast size would allow adequate cosmesis after volume loss from partial mastectomy). * Tumor must not involve the overlying skin or underlying chest wall, based on imaging evaluation and/or clinical exam. * Greatest tumor dimension is \<3 cm based on US. MR imaging measurements can be included only if performed BEFORE the biopsy (postbiopsy measurements can be larger as a result of hematoma formation or increased edema). * Tumor must be unifocal. * Patients must be \> 45 years old. * The tumor must be visible on a CT scan. * Patients must undergo MR imaging for work-up to aid in tumor delineation and to rule out additional foci of disease. If additional foci of disease are found to be present, then these must be biopsied with negative results to proceed with treatment. * The tumor must be clinically and radiographically N0 (node negative). If a suspicious node is visualized, it must be biopsied with negative results. * Patients must be estrogen-receptor positive. * Patients must be HER2neu negative. * Patients must weigh \<150 kg (330 lb), which is the limit of the imaging loader. * Patients must be \<6'6" in height, again because of instrumentation limitations. * Patients must be able to lie prone for treatment. * Patients must have no lymphovascular invasion on biopsy. * Patients may be taking hormonal therapy prior to initiation of treatment. This will be documented.	* Multicentric disease. * Prior RT to the involved breast. * Inability to fit into the immobilization breast cup because of breast size or other anatomic reasons. * Inability to obtain an adequate seal when using the immobilization breast cup. * Male sex. * Breast implants. * Patient cannot comfortably lie in the prone position (i.e., physical disability). * Patients who are planned to be treated surgically with a mastectomy. * Tumor \<5 mm from the skin surface or chest wall on clinical exam and/or radiographic imaging. * Tumor size \>3 cm. * Patients with psychiatric or addictive disorders that would preclude obtaining informed consent or study completion. * Patients who are pregnant or lactating (because of potential RT exposure to the fetus and unknown effects of RT in lactating women). * Patient unable to undergo MR imaging (e.g., because of known contrast reaction or concerns about contrast and existing health status). * Lymphovascular invasion on original biopsy. * Tumor histologies other than invasive ductal carcinoma (including invasive lobular carcinoma). * ER-negative tumors. * HER2neu-positive tumors. * Pure ductal carcinoma in situ (no invasive component). * Weight \>330 lb * Prior ipsilateral breast cancer. * Diffuse calcifications on mammogram (BIRADS 3, 4, 5).

Inclusion Criteria

Exclusion Criteria

* Patients must sign consent for study participation.
* Patients must be female with a diagnosis of invasive ductal carcinoma. Lobular histologies will not be included, because of difficulty in defining the extent of disease with imaging.
* Patients must be deemed appropriate candidates for breast-conserving therapy (i.e., not pregnant, never had RT to the treated breast, breast size would allow adequate cosmesis after volume loss from partial mastectomy).
* Tumor must not involve the overlying skin or underlying chest wall, based on imaging evaluation and/or clinical exam.
* Greatest tumor dimension is \<3 cm based on US. MR imaging measurements can be included only if performed BEFORE the biopsy (postbiopsy measurements can be larger as a result of hematoma formation or increased edema).
* Tumor must be unifocal.
* Patients must be \> 45 years old.
* The tumor must be visible on a CT scan.
* Patients must undergo MR imaging for work-up to aid in tumor delineation and to rule out additional foci of disease. If additional foci of disease are found to be present, then these must be biopsied with negative results to proceed with treatment.
* The tumor must be clinically and radiographically N0 (node negative). If a suspicious node is visualized, it must be biopsied with negative results.
* Patients must be estrogen-receptor positive.
* Patients must be HER2neu negative.
* Patients must weigh \<150 kg (330 lb), which is the limit of the imaging loader.
* Patients must be \<6'6" in height, again because of instrumentation limitations.
* Patients must be able to lie prone for treatment.
* Patients must have no lymphovascular invasion on biopsy.
* Patients may be taking hormonal therapy prior to initiation of treatment. This will be documented.

* Multicentric disease.
* Prior RT to the involved breast.
* Inability to fit into the immobilization breast cup because of breast size or other anatomic reasons.
* Inability to obtain an adequate seal when using the immobilization breast cup.
* Male sex.
* Breast implants.
* Patient cannot comfortably lie in the prone position (i.e., physical disability).
* Patients who are planned to be treated surgically with a mastectomy.
* Tumor \<5 mm from the skin surface or chest wall on clinical exam and/or radiographic imaging.
* Tumor size \>3 cm.
* Patients with psychiatric or addictive disorders that would preclude obtaining informed consent or study completion.
* Patients who are pregnant or lactating (because of potential RT exposure to the fetus and unknown effects of RT in lactating women).
* Patient unable to undergo MR imaging (e.g., because of known contrast reaction or concerns about contrast and existing health status).
* Lymphovascular invasion on original biopsy.
* Tumor histologies other than invasive ductal carcinoma (including invasive lobular carcinoma).
* ER-negative tumors.
* HER2neu-positive tumors.
* Pure ductal carcinoma in situ (no invasive component).
* Weight \>330 lb
* Prior ipsilateral breast cancer.
* Diffuse calcifications on mammogram (BIRADS 3, 4, 5).

Contacts and Locations

Study Contact

Elizabeth Nichols, MD

CONTACT

410-328-6080

enichols1@umm.edu

Caitlin Eggleston

CONTACT

410-328-7586

caitlineggleston@umm.edu

Principal Investigator

Elizabeth Nichols, MD

PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Study Locations (Sites)

UMMC

Baltimore, Maryland, 21201

United States

Upper Chesapeake Health

Bel Air, Maryland, 21014

United States

Central Maryland Oncology Center

Columbia, Maryland, 21044

United States

Baltimore Washington Medical Center

Glen Burnie, Maryland, 21061

United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Elizabeth Nichols, MD, PRINCIPAL_INVESTIGATOR, University of Maryland, Baltimore

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-15

Study Completion Date2028-12

Study Record Updates

Study Start Date2021-09-15

Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

Breast Cancer