RECRUITING

GammaPod Registry and Quality of Life Nomogram

Conditions

Breast Cancer Female Breast Nomogram Breast Cancer Quality of Life GammaPod Registry

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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

This study is a prospective, single arm study (registry) summarizing patient-level adverse-event and tumor outcomes as well as a number of feasibility and dosimetric characteristics of delivering a single-fraction boost with the GammaPod.

Official Title

Tumor Bed Boost Using a Breast Specific Radiosurgery Device, The GammaPodTM: Registry Study and Evaluation of Quality of Life With Development of Sizing Nomogram

Quick Facts

Study Start:2019-01-03

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03562273

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:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* The patient must sign consent for study participation. * The patient must be female and have a diagnosis of an invasive or non-invasive breast cancer that was treated surgically by a partial mastectomy. * The patient must be deemed an appropriate candidate for breast conserving therapy (i.e. not pregnant, never had radiation to the treated breast, breast size would allow adequate cosmesis after volume loss from partial mastectomy). * Patients with involved lymph nodes are candidates for the study. * Surgical margins are negative for invasive (no tumor on ink) or non-invasive breast cancer (2 mm negative margin). * The greatest dimension of the tumor is less than 4cm before surgery. * Multifocal disease is allowed if it was removed by a single lumpectomy resection and the patient remained a candidate for breast conservation. * Age 18 years and older. * Women of childbearing potential (pre-menopausal defined as having a menstrual period within the past 1 year) must have a negative serum pregnancy test or complete a pregnancy waiver form per institutional policy. * The surgical cavity is clearly visible on CT images. Of note, clips are not required but recommended. * The patient must weigh less than 150Kg (330lb), which is the limit of the imaging couch. * The patient must be less than 6'6" in height. * The patient must feel comfortable in the prone position. * Diagnosis of prior contralateral breast cancer is allowed. * Diagnosis of synchronous bilateral cancers is allowed. In this case if bilateral boosts are required, a patient would not have both treatments on the same day. * Oncoplastic reduction surgery is allowed if the lumpectomy cavity can be clearly visualized.	* Patients with proven multi-centric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm). * Prior radiation therapy to that breast or that hemi thorax. * Unable to fit into the immobilization breast cup with an adequate seal. * Male gender. * Patient cannot comfortably be set up in the prone position (i.e. physical disability) * Unable to fit into the breast immobilization device due to breast size or other anatomical reason. * Mastectomy is the surgery performed. * Patient has received prior radiotherapy to the involved breast. * Tumor bed is less than 3 mm from the skin surface. * Greater than 50% of the target volume is above the upper border of the table. * Patients with skin involvement, regardless of tumor size. * Patients with connective tissue disorders specifically systemic lupus erythematosis, scleroderma, or dermatomyositis. * Patients with psychiatric or addictive disorders that would preclude obtaining informed consent. * Patients who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females. * Patients with breast implants/tissue expanders or flap reconstruction.

Inclusion Criteria

Exclusion Criteria

* The patient must sign consent for study participation.
* The patient must be female and have a diagnosis of an invasive or non-invasive breast cancer that was treated surgically by a partial mastectomy.
* The patient must be deemed an appropriate candidate for breast conserving therapy (i.e. not pregnant, never had radiation to the treated breast, breast size would allow adequate cosmesis after volume loss from partial mastectomy).
* Patients with involved lymph nodes are candidates for the study.
* Surgical margins are negative for invasive (no tumor on ink) or non-invasive breast cancer (2 mm negative margin).
* The greatest dimension of the tumor is less than 4cm before surgery.
* Multifocal disease is allowed if it was removed by a single lumpectomy resection and the patient remained a candidate for breast conservation.
* Age 18 years and older.
* Women of childbearing potential (pre-menopausal defined as having a menstrual period within the past 1 year) must have a negative serum pregnancy test or complete a pregnancy waiver form per institutional policy.
* The surgical cavity is clearly visible on CT images. Of note, clips are not required but recommended.
* The patient must weigh less than 150Kg (330lb), which is the limit of the imaging couch.
* The patient must be less than 6'6" in height.
* The patient must feel comfortable in the prone position.
* Diagnosis of prior contralateral breast cancer is allowed.
* Diagnosis of synchronous bilateral cancers is allowed. In this case if bilateral boosts are required, a patient would not have both treatments on the same day.
* Oncoplastic reduction surgery is allowed if the lumpectomy cavity can be clearly visualized.

* Patients with proven multi-centric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm).
* Prior radiation therapy to that breast or that hemi thorax.
* Unable to fit into the immobilization breast cup with an adequate seal.
* Male gender.
* Patient cannot comfortably be set up in the prone position (i.e. physical disability)
* Unable to fit into the breast immobilization device due to breast size or other anatomical reason.
* Mastectomy is the surgery performed.
* Patient has received prior radiotherapy to the involved breast.
* Tumor bed is less than 3 mm from the skin surface.
* Greater than 50% of the target volume is above the upper border of the table.
* Patients with skin involvement, regardless of tumor size.
* Patients with connective tissue disorders specifically systemic lupus erythematosis, scleroderma, or dermatomyositis.
* Patients with psychiatric or addictive disorders that would preclude obtaining informed consent.
* Patients who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females.
* Patients with breast implants/tissue expanders or flap reconstruction.

Contacts and Locations

Study Contact

Elizabeth M. Nichols, M.D.

CONTACT

410-328-2324

enichols1@umm.edu

Madiha Qutab, M.S.

CONTACT

410-328-6472

madiha.qutab@umm.edu

Principal Investigator

Elizabeth M. Nichols, M.D.

PRINCIPAL_INVESTIGATOR

University of Maryland

Study Locations (Sites)

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

UTSouthwestern

Dallas, Texas, 75390

United States

Collaborators and Investigators

Sponsor: University of Maryland, Baltimore

Elizabeth M. Nichols, M.D., PRINCIPAL_INVESTIGATOR, University of Maryland

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 Date2019-01-03

Study Completion Date2027-12

Study Record Updates

Study Start Date2019-01-03

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

Breast Nomogram
Breast Cancer Quality of Life
GammaPod Registry

Additional Relevant MeSH Terms

Breast Cancer Female