RecruitingNCT03562273

GammaPod Registry and Quality of Life Nomogram

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

Sponsor

University of Maryland, Baltimore

Enrollment

160 participants

Start Date

Jan 3, 2019

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Female

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This registry study collects information about quality of life and treatment outcomes for women with breast cancer who receive targeted breast radiation using a specialized device called GammaPod, which precisely treats just the area where the tumor was removed. **You may be eligible if...** - You are a woman who has been diagnosed with invasive or non-invasive (in-situ) breast cancer - You had surgery to remove just the tumor (partial mastectomy or lumpectomy), not the whole breast - Your surgical margins were clear (no cancer cells at the edges of the removed tissue) - Your tumor was smaller than 4 cm before surgery - Your doctor has determined you are a good candidate for breast-conserving therapy **You may NOT be eligible if...** - You are pregnant - You have previously had radiation to the same breast - Your breast size would not allow good cosmetic results after the lumpectomy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONQuality Of Life Sizing Nomogram

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.