Trial Outcomes & Findings for Novel Lung Functional Imaging for Personalized Radiotherapy (NCT NCT02308709)
NCT ID: NCT02308709
Last Updated: 2022-11-10
Results Overview
Number of subjects experiencing Grade ≥3 AEs, i.e., Grade ≥3 radiation pneumonitis, grade ≥3 esophagitis, or other grade ≥3 AEs, defined as definitely, probably, or possibly related to 4D CT ventilation image-guided personalized radiotherapy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
12 months
Results posted on
2022-11-10
Participant Flow
Participant milestones
| Measure |
Ventilation Image-guided CFRT or SBRT
Patients will receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions
Ventilation image-guided radiotherapy: Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions
|
|---|---|
|
Overall Study
STARTED
|
34
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Novel Lung Functional Imaging for Personalized Radiotherapy
Baseline characteristics by cohort
| Measure |
Ventilation Image-guided Radiotherapy
n=34 Participants
Patients will receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions
Ventilation image-guided radiotherapy: Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
29 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 12 monthsNumber of subjects experiencing Grade ≥3 AEs, i.e., Grade ≥3 radiation pneumonitis, grade ≥3 esophagitis, or other grade ≥3 AEs, defined as definitely, probably, or possibly related to 4D CT ventilation image-guided personalized radiotherapy.
Outcome measures
| Measure |
Ventilation Image-guided Radiotherapy
n=33 Participants
Patients will receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions
Ventilation image-guided radiotherapy: Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions
|
Ventilation Image-guided CFRT
Patients who receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions and who receive conventionally fractionated radiotherapy (CFRT).
Ventilation image-guided radiotherapy: Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions
|
|---|---|---|
|
Grade ≥3 AEs Defined as Definitely, Probably, or Possibly Related to 4D CT Ventilation Image-guided Personalized Radiotherapy
|
5 participants
|
—
|
SECONDARY outcome
Timeframe: 2 yearsNumber of participants with Grade ≥ 2 radiation pneumonitis adverse event graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.
Outcome measures
| Measure |
Ventilation Image-guided Radiotherapy
n=33 Participants
Patients will receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions
Ventilation image-guided radiotherapy: Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions
|
Ventilation Image-guided CFRT
Patients who receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions and who receive conventionally fractionated radiotherapy (CFRT).
Ventilation image-guided radiotherapy: Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions
|
|---|---|---|
|
Radiation Pneumonitis Graded by CTCAE v4.0
|
5 participants
|
—
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: The number of participants analyzed are smaller than 33 due to missing data (disease progression or patient refusal was the main reason).
The median absolute change from baseline in FEV1 (% predicted) at 6 months after treatment.
Outcome measures
| Measure |
Ventilation Image-guided Radiotherapy
n=8 Participants
Patients will receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions
Ventilation image-guided radiotherapy: Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions
|
Ventilation Image-guided CFRT
n=11 Participants
Patients who receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions and who receive conventionally fractionated radiotherapy (CFRT).
Ventilation image-guided radiotherapy: Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions
|
|---|---|---|
|
Post-treatment Change in Forced Expiratory Volume in 1 Second (FEV1)
|
6 Percent of predicted FEV1
Interval -2.0 to 23.0
|
-1 Percent of predicted FEV1
Interval -16.0 to 10.0
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsPopulation: The number of participants analyzed are smaller than 33 due to missing data (disease progression or patient refusal was the main reason).
The median absolute change from baseline in DLCO (% predicted) at 6 months after treatment.
Outcome measures
| Measure |
Ventilation Image-guided Radiotherapy
n=3 Participants
Patients will receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions
Ventilation image-guided radiotherapy: Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions
|
Ventilation Image-guided CFRT
n=4 Participants
Patients who receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions and who receive conventionally fractionated radiotherapy (CFRT).
Ventilation image-guided radiotherapy: Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions
|
|---|---|---|
|
Post-treatment Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
|
-10 Percent of predicted DLCO
Interval -27.0 to 6.0
|
-0.5 Percent of predicted DLCO
Interval -4.0 to 9.0
|
Adverse Events
Ventilation Image-guided Radiotherapy
Serious events: 2 serious events
Other events: 33 other events
Deaths: 22 deaths
Serious adverse events
| Measure |
Ventilation Image-guided Radiotherapy
n=33 participants at risk
Patients will receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions
Ventilation image-guided radiotherapy: Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions
|
|---|---|
|
Gastrointestinal disorders
Esophagitis
|
6.1%
2/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
Other adverse events
| Measure |
Ventilation Image-guided Radiotherapy
n=33 participants at risk
Patients will receive 4D CT ventilation image-guided personalized radiotherapy treatment that selectively avoids irradiating highly-functional lung regions
Ventilation image-guided radiotherapy: Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.1%
2/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Metabolism and nutrition disorders
Anorexia
|
6.1%
2/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
15.2%
5/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Eye disorders
Blurred vision
|
6.1%
2/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Cardiac disorders
Chest pain
|
9.1%
3/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Cardiac disorders
Chest wall pain
|
9.1%
3/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Gastrointestinal disorders
Constipation
|
27.3%
9/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
54.5%
18/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Investigations
Creatinine increased
|
12.1%
4/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Metabolism and nutrition disorders
Dehydration
|
15.2%
5/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Psychiatric disorders
Depression
|
6.1%
2/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
21.2%
7/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
9.1%
3/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Gastrointestinal disorders
Diarrhea
|
6.1%
2/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.1%
2/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Gastrointestinal disorders
Dysphagia
|
30.3%
10/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
48.5%
16/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
General disorders
Edema limbs
|
6.1%
2/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.1%
2/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Gastrointestinal disorders
Esophagitis
|
51.5%
17/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
General disorders
Fatigue
|
72.7%
24/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
General disorders
Fever
|
12.1%
4/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.1%
2/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Respiratory, thoracic and mediastinal disorders
Globus sensation
|
9.1%
3/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Nervous system disorders
Headache
|
9.1%
3/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Renal and urinary disorders
Hematuria
|
6.1%
2/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
6.1%
2/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.2%
7/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
6.1%
2/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.1%
2/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Psychiatric disorders
Insomnia
|
12.1%
4/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
9.1%
3/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Investigations
Lymphocyte count decreased
|
12.1%
4/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Gastrointestinal disorders
Nausea
|
24.2%
8/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Investigations
Neutrophil count decreased
|
6.1%
2/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
General disorders
Non-cardiac chest pain
|
24.2%
8/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.1%
2/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Reproductive system and breast disorders
Pelvic pain
|
6.1%
2/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
15.2%
5/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis (radiographic)
|
18.2%
6/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Renal and urinary disorders
Proteinuria
|
6.1%
2/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis (radiographic)
|
18.2%
6/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.1%
2/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
12.1%
4/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
|
Investigations
White blood cell decreased
|
12.1%
4/33 • Serious and other adverse events assessed for up to 12 months after treatment is completed, an average of 2 years. All cause mortality assessed for up to about 2.5 year after treatment complete.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place