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GammaPod Registry for Breast Cancer Quality of Life

This study is looking at how a specific radiation treatment, called the Quality Of Life Sizing Nomogram (RADIATION), affects women with breast cancer. If you qualify and choose to participate, you would receive a single dose of radiation (8 Gy in 1 fraction) to the area where your tumor was removed, right before starting your regular whole breast radiation. Researchers want to understand how this treatment impacts your quality of life, which will be measured one year after joining the study. This study is for women aged 18 and older who have been diagnosed with invasive or non-invasive breast cancer and had a partial mastectomy (lumpectomy). The study is currently unclear on its recruitment status.

Study design
This is an observational study, meaning researchers will collect information about your treatment and outcomes. It aims to enroll 160 participants.
What's involved
If you join, you will receive the tumor bed boost radiation just before starting whole breast radiation. Your quality of life will be evaluated at one year.
Compensation
Not stated in the trial record.
Follow-up
Your quality of life will be evaluated at one year after joining the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03562273

GammaPod Registry and Quality of Life Nomogram

Recruiting
Not specifiedAges 18+Observational
University of Maryland, Baltimore
~160 participants
Updated 2026-02-20 on ClinicalTrials.gov
What's tested:Quality Of Life Sizing Nomogram

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Quality Of Life Evaluations
Measured over 1 year

Conditions

Breast Cancer Female

Explore related trials

Breast Carcinoma

Where it's being run

4 sites across 2 states
Maryland3
Texas1

Study leadership

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

Who to contact

Elizabeth M. Nichols, M.D.
[email protected]
410-328-2324
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Quality Of Life Evaluations1 year

    Evaluate the quality of life impact shortening treatment by 3-4 fractions may have on a patient via questionnaire(s).