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Novel Lung Functional Imaging for Personalized Radiotherapy
NA trial testing Ventilation image-guided radiotherapy in Lung Cancer in 34 participants. Completed in 19 November 2021.
| Lead sponsor | University of California, Davis |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 34 |
| Start date | 15 September 2014 |
| Primary completion | 19 November 2020 |
| Estimated completion | 19 November 2021 |
| Sites | 1 location across United States |
University of California, Davis
Adults 18 to 80, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Ventilation Image-guided Radiotherapy | 5 |
Number 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.
| Group | Value | 95% CI |
|---|---|---|
| Ventilation Image-guided Radiotherapy | 5 |
The median absolute change from baseline in FEV1 (% predicted) at 6 months after treatment.
| Group | Value | 95% CI |
|---|---|---|
| Ventilation Image-guided SBRT | 6 | -2 – 23 |
| Ventilation Image-guided CFRT | -1 | -16 – 10 |
The median absolute change from baseline in DLCO (% predicted) at 6 months after treatment.
| Group | Value | 95% CI |
|---|---|---|
| Ventilation Image-guided CFRT | -10 | -27 – 6 |
| Ventilation Image-guided SBRT | -0.5 | -4 – 9 |
Time frame: 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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Ventilation Image-guided R… |
|---|---|---|
| Esophagitis | Gastrointestinal disorders | — |
| Reaction | System | Ventilation Image-guided R… |
|---|---|---|
| Fatigue | General disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Esophagitis | Gastrointestinal disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Dysphagia | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Non-cardiac chest pain | General disorders | — |
| Dermatitis | Skin and subcutaneous tissue disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Pneumonitis (radiographic) | Respiratory, thoracic and mediastinal disorders | — |
| Pulmonary fibrosis (radiographic) | Respiratory, thoracic and mediastinal disorders | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — |
| Creatinine increased | Investigations | — |
| Fever | General disorders | — |
| Insomnia | Psychiatric disorders | — |
| Lymphocyte count decreased | Investigations | — |
| Sore throat | Respiratory, thoracic and mediastinal disorders | — |
| White blood cell decreased | Investigations | — |
| Chest pain | Cardiac disorders | — |
| Chest wall pain | Cardiac disorders | — |
| Dermatitis radiation | Injury, poisoning and procedural complications | — |
| Globus sensation | Respiratory, thoracic and mediastinal disorders | — |
| Headache | Nervous system disorders | — |
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Blurred vision | Eye disorders | — |
| Depression | Psychiatric disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Dyspepsia | Gastrointestinal disorders | — |
| Edema limbs | General disorders | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — |
| Gastroesophageal reflux disease | Gastrointestinal disorders | — |
| Hematuria | Renal and urinary disorders | — |
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
Most-reported serious reactions: Esophagitis.
Data from ClinicalTrials.gov NCT02308709 adverse events section.
The primary objective of this study is to assess the safety and feasibility of personalized radiotherapy with four-dimensional (4D) computed tomography (CT)-based pulmonary ventilation imaging, which selectively avoids irradiating highly-functional lung regions.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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