Feasibility of Mobile-CT-Assisted Bronchoscopy for the Diagnosis of Lung

Status Active, not recruiting

Clinical Trial Summary

This study investigates whether using a mobile-CT-assisted bronchoscopy (M-CAB) during a bronchoscopy procedure will better enable the study staff to reach the lung tumor, perform a biopsy, and obtain a diagnosis. One method that doctors use for diagnosing lung tumors is bronchoscopy guided by an X-ray machine (called fluoroscope). Though much better guidance could be provided with a CT scanner when compared to the fluoroscope, the standard CT equipment is very large, fixed in a radiology room, and difficult to use with bronchoscopy. Mobile CT imaging systems may more easily and effectively perform the same tasks of the standard CT imaging in the bronchoscopy room, offering better guidance than the standard fluoroscope.

Clinical Trial Description

PRIMARY OBJECTIVE I. To determine the added value of mobile-CT)-assisted bronchoscopy (M-CAB) for the diagnosis of peripheral lung nodules defined as the proportion of patients in whom bronchoscopy with radial-probe endobronchial ultrasound (RP-EBUS) and 2-D Fluoroscopy is non-diagnostic (lesion is not reached or rapid-onsite cytology is non-diagnostic) and diagnosis is obtained after utilizing mobile-CT assistance. SECONDARY OBJECTIVES: I. Describe the navigational yield of bronchoscopy with RP-EBUS/2-dimensional (2-D) fluoroscopy for peripheral nodules. II. Describe the diagnostic yield of bronchoscopy with RP-EBUS/2-D fluoroscopy for peripheral nodules. III. Describe the mobile-CT (M-CT) added navigational yield. IV. Describe the sensitivity for malignancy of bronchoscopy with RP-EBUS/2-D fluoroscopy and its increase (if any) provided by mobile-CT assistance. V. Describe anatomical and procedural characteristics that can influence navigational and diagnostic yield (tumor location, tumor characteristics -solid, semisolid-, air-bronchus sign, biopsy tool, relationship between biopsy tool/tumor). VI. Describe procedure duration. VII. Describe time required to obtain mobile CT scans VIII. Describe fluoroscopy time and estimate radiation dose to the patient. IX. Describe procedural complications. OUTLINE: Patients undergo RP-EBUS bronchoscopy per standard of care. If the study staff cannot reach the target lesion or is unable to determine a diagnosis, patients undergo bronchoscopy using mobile CT imaging. Patients' medical records are also reviewed for up to 6 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04995172
Study type	Observational
Source	M.D. Anderson Cancer Center
Contact
Status	Active, not recruiting
Phase
Start date	April 19, 2021
Completion date	December 31, 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05078918` - Comprehensive Care Program for Their Return to Normal Life Among Lung Cancer Survivors	N/A
Completed	`NCT04508270` - Significance of Early Mobilization After VATS-L
Active, not recruiting	`NCT03667716` - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.	Phase 1
Completed	`NCT05469425` - Home-based Preoperative Exercise Training for Lung Cancer Patients Undergoing Surgery	N/A
Recruiting	`NCT05046067` - Feasibility Study of Anatomical Modeling for Image Guided Thoracic Surgery	N/A
Terminated	`NCT03090880` - Prophylaxis of Venous Thromboembolism in Advanced Lung Cancer (PROVE)	Phase 3
Recruiting	`NCT05596760` - Promoting Goals-of-Care Discussions for Patients With Memory Problems and Their Caregivers	N/A
Completed	`NCT02498860` - Efficacy and Safety of Adjuvant Pemetrexed Plus Cisplatin for Adenocarcinoma of Lung	Phase 2
Completed	`NCT02952261` - Application of 3D Printing Technique in Small Pulmonary Nodule Localization	N/A
Not yet recruiting	`NCT06024538` - Role of Cancer-associated Fibroblast, MDSCs and Immune Cell Interplays in the Resistance of Non-small Cell Lung Cancer to Anti-PD1/PD-L1 Therapies
Recruiting	`NCT02965300` - The Value of VOCs Analysis in Exhaled Breath for Pulmonary Benign and Malignant Lesion Diagnosis	N/A
Completed	`NCT02616211` - An Integrated Approach to Treating Recurrent Thoracic Carcinomas Resistant to Tyrosine Kinase Inhibitors
Recruiting	`NCT00765986` - Pilot Study of 18F-FAZA in Assessing Early Functional Response in Patients With Inoperable Non Small Cell Lung Cancer Undergoing Radiotherapy or Chemo-radiotherapy	N/A
Completed	`NCT03320044` - Early Diagnosis of Small Pulmonary Nodules by Multi-omics Sequencing
Recruiting	`NCT03655015` - Patient-derived Organoid Model and Circulating Tumor Cells for Treatment Response of Lung Cancer
Completed	`NCT03741868` - Symptom Burden and Unmet Supportive Care Needs in Lung Cancer Patients Undergoing First or Second Line Immunotherapy
Not yet recruiting	`NCT05179408` - Telerehabilitation Following Lung Cancer	N/A
Completed	`NCT03749512` - NLCR in Prediction of the Grade of Lung Tumor.
Recruiting	`NCT03664843` - Circulating Tumor DNA Longitudinal Monitoring in Stage III-IV Lung Cancer Patients
Completed	`NCT01261507` - Reader Study of DeltaView™ Chest Radiograph Software	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Feasibility of Mobile-CT-Assisted Bronchoscopy for the Diagnosis of Lung Lesion

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms