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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Radiation
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Maryland
Upper Chesapeake Health
RECRUITING
Bel Air
Central Maryland Oncology Center
RECRUITING
Columbia
Baltimore Washington Medical Center
RECRUITING
Glen Burnie
Texas
UTSouthwestern
RECRUITING
Dallas
Contact Information
Primary
Elizabeth M. Nichols, M.D.
enichols1@umm.edu
410-328-2324
Backup
Madiha Qutab, M.S.
madiha.qutab@umm.edu
410-328-6472
Time Frame
Start Date: 2019-01-03
Estimated Completion Date: 2027-12
Participants
Target number of participants: 160
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Texas, Southwestern Medical Center at Dallas
Leads: University of Maryland, Baltimore

This content was sourced from clinicaltrials.gov