GammaPod Dose Escalation Radiation for Early Stage Breast Cancer

Conditions

• Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

45 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• GammaPod Radiation — RADIATION
  The basic design is a dose-escalation phase Ib study with 4 predefined dose levels. With this study treatment, participants will receive the dose level assigned treatment of radiation therapy before the lumpectomy surgery.

Study Details

The GammaPod machine was made by Xcision Medical Systems and is already FDA cleared to deliver focused radiation within the breast. Unlike current radiation machines, the GammaPod was designed specifically for treating breast cancer. The GammaPod can pinpoint radiation to the tumor bed in the breast which lowers the amount of radiation to nearby tissues. The machine uses a breast cup system to hold the breast in place for the treatment. This breast cup system was tested at MSGCCC (Marlene Stewart Greenebaum Comprehensive Cancer Center). Patients reported this system was more comfortable than an MRI or mammogram. The cup system was able to securely position the breast for treatment in the correct location. Receiving radiation before surgery is not a new concept in cancer management. Preoperative radiation has proven to result in improved disease free survival in certain types of cancer. With this study treatment, the participants will receive a dose of breast radiation therapy before the lumpectomy surgery. The lumpectomy surgery is where they remove the participant's tumor. The purpose of this research study is to determine a safe and effective dose of pre-operative radiation to treat early stage breast cancer. The pre-operative radiation is delivered using the FDA approved, GammaPod machine. The study will also determine the cosmesis of pre-operative radiation at different doses. Cosmesis is another word for looking at skin changes. The research team will use questionnaires for patient and physicians to assess adverse cosmesis changes as accurately as possible. In addition, the investigators are going to assess radiation related changes using photo software analysis tools and patients quality of life.

Key Dates

Start date

Sep 15, 2021

Status verified

Feb 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2030

Study Design

Enrollment

50 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Active Comparator: Dose Level 1: 21 Gy
  Participants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy.
• Active Comparator: Dose Level 2: 24 Gy
  Participants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy.
• Active Comparator: Dose Level 3: 27 Gy
  Participants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy.
• Active Comparator: Dose Level 4: 30 Gy
  Participants will receive radiation therapy to the partial breast using the GammaPod technology before a lumpectomy.

Primary Outcome Measure

Establish the single-fraction radiation dose (MTD) [ Time Frame: 5 years ]

Central Contacts

• Elizabeth Nichols, MD
  410-328-6080
  [email protected]
• Caitlin Eggleston
  410-328-7586
  [email protected]

Locations (4)

Find similar trials in Baltimore, MD

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