Clinical trial · Interventional
4-Dimensional CT Derived Ventilation Versus SPECT Aerosol Ventilation in Patients With Thoracic Malignancies
Phase II Trial Comparing 4-Dimensional Computed Tomography Derived Ventilation Versus SPECT/CT Tc-99m Aerosol Ventilation in Patients With Thoracic Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Objectives: Primary Objective: 1\. To determine the correlation between 4-dimensional computed tomography (4D CT) derived ventilation and single photon emission tomography (SPECT) aerosol Tc-99m determined ventilation. Secondary Objective: 1. To evaluate the reproducibility of the 4D CT derived ventilation and to obtain an estimate of the variance in a single setting. 2. To assess the correlation between hypoperfused and hypoventilated pulmonary regions in patients with thoracic malignancies. 3. To investigate the effect of continuous positive airway pressure (CPAP) on ventilation and tumor motion.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 4D CT scans | Procedure | — | UNRESOLVED |
| Lung Function Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 4-DCT Ventilation Validation
- interventionNames
- Procedure: 4D CT scans
- Procedure: Lung Function Imaging
Primary outcomes (1)
- measure
- Correlation between 4-dimensional computed tomography (4D CT) derived ventilation and single photon emission tomography (SPECT) aerosol Tc-99m determined ventilation
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Patients with pathologic diagnosis of esophagus or lung cancer (Stage I through IV). 2. Patients must be able to lie flat for the duration of the treatment planning sessions. 3. Patients must sign informed consent. 4. Patients who are scheduled to receive radiation therapy. 5. A cohort of 6 lung cancer patients whose primary tumors move greater than 1 cm will be recruited (CPAP cohort). Exclusion Criteria: 1. Significant pleural effusion as evaluated by the attending Radiation Oncologist is excluded. 2. Women of childbearing potential (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months \[i.e., who has had menses at any time in the preceding 24 consecutive months\]) and male participants must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study. 3. Patients with severe COPD or asthma will be excluded from the CPAP cohort.
References
Publications (0)
Data not yet available