GammaPod Registry and Quality of Life Nomogram

Part of paid clinical trials in Bel Air, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT03562273
Status
Recruiting
Apply to this trial

Conditions

  • Breast Cancer Female

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jan 3, 2019
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
160 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Quality Of Life Evaluations [ Time Frame: 1 year ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Upper Chesapeake HealthBel AirMaryland21014
Linda Romar, BS
[email protected]
443-643-1877
Jack Hong, MD (SUB_INVESTIGATOR)
Central Maryland Oncology CenterColumbiaMaryland21044
Madiha Qutab, M.S.
[email protected]
443-328-6472
Sally Cheston, MD (SUB_INVESTIGATOR)
Baltimore Washington Medical CenterGlen BurnieMaryland21061
Pilar Strycula, RN, BSN
[email protected]
410-553-8110
Wendla Citron, MD (SUB_INVESTIGATOR)
UTSouthwesternDallasTexas75390
Sara Gamal
[email protected]
214-645-8519
Asal Rahimi, MD, MS (PRINCIPAL_INVESTIGATOR)

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