Trial Outcomes & Findings for Breast Cup Immobilization Device II (GCC 1047) (NCT NCT01704547)

Last Updated: 2023-02-01

Results Overview

Complete clinical feasibility of using a breast cup immobilization device for prone breast irradiation in terms of both geometric and dosimetric accuracy. Measurements were able to be completed on 25 participants through treatment planning CT scans.

Recruitment status

COMPLETED

Target enrollment

25 participants

Primary outcome timeframe

One year

Results posted on

2023-02-01

Participant Flow

Participant milestones

Participant milestones
Measure	Breastcup Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II
Overall Study STARTED	25
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Breastcup Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II
Overall Study Physician Decision	4
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Breast Cup Immobilization Device II (GCC 1047)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Breastcup n=25 Participants Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: One year

Population: Analysis was done through imaging assessment. Completed on all 25 patients.

Outcome measures

Outcome measures
Measure	Breastcup n=25 Participants Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II
Breast Cup Immobilization Device II (GCC 1047) Feasibility	25 Participants

SECONDARY outcome

Timeframe: One year

Assess patient comfort while wearing the breast cup immobilization device. Patients provided questionnaire to rate comfort level (discomfort was ranked from 0 (no pain) to 5 (very painful).

Outcome measures

Outcome measures
Measure	Breastcup n=25 Participants Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II
Breast Cup Immobilization Device II (GCC 1047) Comfort	0.6 score on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 1 year

Candidates being assessed based on their breast size, tumor or tumor bed size, tumor or tumor bed location and normal tissue proximity by evaluating GammaPod treatment plans developed using the acquired CT images. Through images, patients were evaluated for their ability to meet the requirements for GammaPod treatment based off the factors mentioned previously.

Outcome measures

Outcome measures
Measure	Breastcup n=25 Participants Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II
Number of Participants That Were Favorable Candidates for Receiving GammaPod Treatment	25 Participants

Adverse Events

Breastcup

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Breastcup n=25 participants at risk Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II
Skin and subcutaneous tissue disorders Blistering	4.0% 1/25 • 30 days

Additional Information

Elizabeth M. Nichols, MD

UMGCCC

Phone: 410-328-2324

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place