Head and Neck Neoplasms
Conditions
Keywords
Kilovoltage Imaging, Cone-beam CT, CBCT, radiation therapy, head and neck neoplasms
Brief summary
To evaluate the use of cone beam computed tomography in treating head and neck to hopefully reduce side effects
Detailed description
The general purpose of this study is to evaluate Kilovoltage (kv) Imaging, specifically the Cone-beam CT (CBCT) scan device, to assess the accuracy of radiation therapy treatment delivery for patients with head and neck neoplasms
Interventions
DEVICEPTV Reduction
The margin around the area to be treated with radiation is decreased due the image guidance of the cone beam CT
Sponsors
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* any patient receiving radiation therapy for a head and neck tumor assigned to the new Elekta Synergy Linare Accelerator
Exclusion criteria
* NA
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Interfraction Shift of Patients Undergoing Radiotherapy | Daily prior to radiation | Determine the magnitude of the systematic error of patient positioning as determined by cone beam CT (CBCT) and the desired placement based on the treatment planning CT scan. Every day, prior to radiation treatment, a CBCT will be performed. The CBCT images will be compared to the radiation therapy planning CT image just taken. |
| Average Residual Error Motion of Patients Undergoing Radiotherapy | Daily after each radiotherapy treatment | To determine the magnitude of random variance (random error) in radiotherapy treatment of head and neck neoplasms |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cone Beam CT Undergo a cone beam CT scan | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Cone Beam CT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants |
| Age, Continuous | 58.19 years STANDARD_DEVIATION 12.21 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 30 |
| serious Total, serious adverse events | 1 / 30 |
Outcome results
Primary
Average Interfraction Shift of Patients Undergoing Radiotherapy
Determine the magnitude of the systematic error of patient positioning as determined by cone beam CT (CBCT) and the desired placement based on the treatment planning CT scan. Every day, prior to radiation treatment, a CBCT will be performed. The CBCT images will be compared to the radiation therapy planning CT image just taken.
Time frame: Daily prior to radiation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cone Beam CT | Average Interfraction Shift of Patients Undergoing Radiotherapy | Medial-lateral dimension | 1.4 millimeters | Standard Deviation 1.4 |
| Cone Beam CT | Average Interfraction Shift of Patients Undergoing Radiotherapy | Superoinferior dimension | 1.7 millimeters | Standard Deviation 1.9 |
| Cone Beam CT | Average Interfraction Shift of Patients Undergoing Radiotherapy | Anteroposterior dimension | 1.8 millimeters | Standard Deviation 2.1 |
Primary
Average Residual Error Motion of Patients Undergoing Radiotherapy
To determine the magnitude of random variance (random error) in radiotherapy treatment of head and neck neoplasms
Time frame: Daily after each radiotherapy treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cone Beam CT | Average Residual Error Motion of Patients Undergoing Radiotherapy | Medial-lateral dimension | 0.7 millimeters | Standard Deviation 0.8 |
| Cone Beam CT | Average Residual Error Motion of Patients Undergoing Radiotherapy | Superoinferior dimension | 0.9 millimeters | Standard Deviation 0.9 |
| Cone Beam CT | Average Residual Error Motion of Patients Undergoing Radiotherapy | Anteroposterior dimension | 0.9 millimeters | Standard Deviation 0.9 |