GammaPod Registry and Quality of Life Nomogram

NCT03562273 | Recruiting DMC FDA Device

• 1 other identifier: HP-00080885
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Breast Cancer Female

Keywords

Breast Nomogram; Breast Cancer Quality of Life; GammaPod Registry

Outcome Measures

Primary Outcomes (1)

• Quality Of Life Evaluations

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

  1 year

Secondary Outcomes (3)

• GammaPod Nomogram construction

  1 year

• Number of participants with treatment related adverse events as assessed by CTCAE v4.0

  ~10 weeks

• Number of participants with treatment related adverse events as assessed by CTCAE v4.0 post one year from treatment

  ~1.5 years

Study Arms (1)

GammaPod Quality of Life Evaluations

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.

Radiation: Quality Of Life Sizing Nomogram

Interventions

Quality Of Life Sizing Nomogram RADIATION

If the participant meets the eligibility criteria of the study, and participant chooses to take part, they will receive the tumor bed boost in 8 Gy in 1 fraction just prior to starting whole breast radiation after joining the study. Treatment to the whole breast will begin within 7-8 days from the TB boost (GammaPodTM) treatment. The radiation therapy will take approximately 6 weeks to complete. Follow-up visits specifically for this study will continue for one year, although the physician will continue to follow as part of routine care.

Also known as: GammaPod Quality Of Life Sizing Nomogram

GammaPod Quality of Life Evaluations

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women with breast cancer

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• University of Texas, Southwestern Medical Center at Dallas: collaborator

Study Sites (4)

Upper Chesapeake Health

Bel Air, Maryland, 21014, United States

RECRUITING

Central Maryland Oncology Center

Columbia, Maryland, 21044, United States

RECRUITING

Baltimore Washington Medical Center

Glen Burnie, Maryland, 21061, United States

RECRUITING

UTSouthwestern

Dallas, Texas, 75390, United States

RECRUITING

Study Officials

• Elizabeth M. Nichols, M.D.

  University of Maryland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth M. Nichols, M.D.

CONTACT

410-328-2324; enichols1@umm.edu

Madiha Qutab, M.S.

CONTACT

410-328-6472; madiha.qutab@umm.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 19, 2018
• Study Start: January 3, 2019
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

US (4)