Trial Outcomes & Findings for The Gamma Pod: A Clinical Feasibility Study Device GCC 1202: The Gamma Pod: A Clinical Feasibility Study (NCT NCT02507960)

Results Overview

Patients must be undergoing breast conserving therapy and PI will evaluate for feasibility by ensuring coverage of the target volume with appropriate dose homogeneity and conformity as defined in the study. Per inclusion criteria, the volume of the tumor bed clinical target volume (CTV) is less than 25% of the whole breast planning target volume (PTV) which is a criteria used for partial breast alone trials (ie. NSABP B-39). If the tumor bed cannot fit this criteria, then patient is unable to be treated utilizing GammaPod.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

1 year

Results posted on

2022-01-14

Participant Flow

Participant milestones

Participant milestones
Measure	Pilot Study The patient will undergo a conventional CT simulation in supine position without the breast immobilization cup. The purpose of the CT simulation is-two-fold: 1) the investigators will see if the TB volume can be accurately delineated and if the TB volume is too large for Gamma Pod boost; and 2) the CT images are used for planning the patient's whole breast irradiation. If, after viewing the CT images and the patient is deemed a study candidate and consents, the participants will receive a second CT-sim and the Gamma Pod TB boost treatment on the same day as described below. The Gamma Pod: Immobilization of breast during radiation. CT simulation: See arm description
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Gamma Pod: A Clinical Feasibility Study Device GCC 1202: The Gamma Pod: A Clinical Feasibility Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pilot Study n=17 Participants The patient will undergo a conventional CT simulation in supine position without the breast immobilization cup. The purpose of the CT simulation is-two-fold: 1) the investigators will see if the TB volume can be accurately delineated and if the TB volume is too large for Gamma Pod boost; and 2) the CT images are used for planning the patient's whole breast irradiation. If, after viewing the CT images and the patient is deemed a study candidate and consents, the participants will receive a second CT-sim and the Gamma Pod TB boost treatment on the same day as described below. The Gamma Pod: Immobilization of breast during radiation. CT simulation: See arm description
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=99 Participants
Age, Categorical >=65 years	10 Participants n=99 Participants
Age, Continuous	66.8 years n=99 Participants
Sex: Female, Male Female	17 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Race/Ethnicity, Customized Ethnicity/Race · White	15 Participants n=99 Participants
Race/Ethnicity, Customized Ethnicity/Race · African American	2 Participants n=99 Participants
Region of Enrollment United States	17 Participants n=99 Participants

PRIMARY outcome

Timeframe: 1 year

Patients must be undergoing breast conserving therapy and PI will evaluate for feasibility by ensuring coverage of the target volume with appropriate dose homogeneity and conformity as defined in the study. Per inclusion criteria, the volume of the tumor bed clinical target volume (CTV) is less than 25% of the whole breast planning target volume (PTV) which is a criteria used for partial breast alone trials (ie. NSABP B-39). If the tumor bed cannot fit this criteria, then patient is unable to be treated utilizing GammaPod.

Outcome measures

Outcome measures
Measure	Pilot Study n=17 Participants The patient will undergo a conventional CT simulation in supine position without the breast immobilization cup. The purpose of the CT simulation is-two-fold: 1) the investigators will see if the TB volume can be accurately delineated and if the TB volume is too large for Gamma Pod boost; and 2) the CT images are used for planning the patient's whole breast irradiation. If, after viewing the CT images and the patient is deemed a study candidate and consents, the participants will receive a second CT-sim and the Gamma Pod TB boost treatment on the same day as described below. The Gamma Pod: Immobilization of breast during radiation. CT simulation: See arm description
Demonstration of the Feasibility and Safety of Delivering a Radiation Treatment Using the GammaPod (TM)	14 Participants

SECONDARY outcome

Timeframe: 2 months

Outcome measures

Outcome measures
Measure	Pilot Study n=17 Participants The patient will undergo a conventional CT simulation in supine position without the breast immobilization cup. The purpose of the CT simulation is-two-fold: 1) the investigators will see if the TB volume can be accurately delineated and if the TB volume is too large for Gamma Pod boost; and 2) the CT images are used for planning the patient's whole breast irradiation. If, after viewing the CT images and the patient is deemed a study candidate and consents, the participants will receive a second CT-sim and the Gamma Pod TB boost treatment on the same day as described below. The Gamma Pod: Immobilization of breast during radiation. CT simulation: See arm description
Number of Participants With Acute Toxicities Measured by Common Terminology Criteria for Adverse Events (CTCAE); The Evaluation of Acute Toxicity During and up to 1 Month After Gamma Pod TB Boost.	14 Participants

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	Pilot Study n=17 Participants The patient will undergo a conventional CT simulation in supine position without the breast immobilization cup. The purpose of the CT simulation is-two-fold: 1) the investigators will see if the TB volume can be accurately delineated and if the TB volume is too large for Gamma Pod boost; and 2) the CT images are used for planning the patient's whole breast irradiation. If, after viewing the CT images and the patient is deemed a study candidate and consents, the participants will receive a second CT-sim and the Gamma Pod TB boost treatment on the same day as described below. The Gamma Pod: Immobilization of breast during radiation. CT simulation: See arm description
Number of Participants With Long-term Toxicities Measured by Common Terminology Criteria for Adverse Events (CTCAE); The Evaluation of Long-term Toxicity at One Year to Assess the Presence of Subcutaneous Fibrosis and Fat Necrosis.	0 Participants

SECONDARY outcome

Timeframe: 1 year

Adverse events from the use of the adhesive spray was measured by photos taken pre-entry and during radiation.

Outcome measures

Outcome measures
Measure	Pilot Study n=17 Participants The patient will undergo a conventional CT simulation in supine position without the breast immobilization cup. The purpose of the CT simulation is-two-fold: 1) the investigators will see if the TB volume can be accurately delineated and if the TB volume is too large for Gamma Pod boost; and 2) the CT images are used for planning the patient's whole breast irradiation. If, after viewing the CT images and the patient is deemed a study candidate and consents, the participants will receive a second CT-sim and the Gamma Pod TB boost treatment on the same day as described below. The Gamma Pod: Immobilization of breast during radiation. CT simulation: See arm description
Efficacy of Medical Adhesive; Number of Participants With Adverse Events From the Use of the Adhesive Spray	1 Participants

Adverse Events

Pilot Study

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pilot Study n=17 participants at risk The patient will undergo a conventional CT simulation in supine position without the breast immobilization cup. The purpose of the CT simulation is-two-fold: 1) the investigators will see if the TB volume can be accurately delineated and if the TB volume is too large for Gamma Pod boost; and 2) the CT images are used for planning the patient's whole breast irradiation. If, after viewing the CT images and the patient is deemed a study candidate and consents, the participants will receive a second CT-sim and the Gamma Pod TB boost treatment on the same day as described below. The Gamma Pod: Immobilization of breast during radiation. CT simulation: See arm description
General disorders Fatigue	58.8% 10/17 • AEs were collected during radiation treatments and during the follow-up time period (per protocol), approximately a duration of 1 year. Systematic assessment during through regular physician assessments.
Skin and subcutaneous tissue disorders Dermatitis	64.7% 11/17 • AEs were collected during radiation treatments and during the follow-up time period (per protocol), approximately a duration of 1 year. Systematic assessment during through regular physician assessments.
Skin and subcutaneous tissue disorders Hyperpigmentation	17.6% 3/17 • AEs were collected during radiation treatments and during the follow-up time period (per protocol), approximately a duration of 1 year. Systematic assessment during through regular physician assessments.
Musculoskeletal and connective tissue disorders Breast Pain	23.5% 4/17 • AEs were collected during radiation treatments and during the follow-up time period (per protocol), approximately a duration of 1 year. Systematic assessment during through regular physician assessments.
General disorders Limb Edema	5.9% 1/17 • AEs were collected during radiation treatments and during the follow-up time period (per protocol), approximately a duration of 1 year. Systematic assessment during through regular physician assessments.
Gastrointestinal disorders Nausea	5.9% 1/17 • AEs were collected during radiation treatments and during the follow-up time period (per protocol), approximately a duration of 1 year. Systematic assessment during through regular physician assessments.

Additional Information

Elizabeth Nichols

University of Maryland Medical Center

Phone: 4103287586

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place