Rapid on-site evaluation (ROSE) for Lung Cancers

Phase-Based Estimates
1
Effectiveness
1
Safety
Health Sciences Centre, Calgary, Canada
+1 More
Rapid on-site evaluation (ROSE) - Procedure
Eligibility
18+
All Sexes
Eligible conditions
Lung Cancers

Study Summary

This study is evaluating whether a new technology can improve the diagnostic yield of PPL biopsies.

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Eligible Conditions

  • Lung Cancers
  • Peripheral Pulmonary Lesions

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Rapid on-site evaluation (ROSE) will improve 1 primary outcome and 5 secondary outcomes in patients with Lung Cancers. Measurement will happen over the course of Intraoperative.

1 month
Peripheral pulmonary lesion diagnostic yield
Sample adequacy for adjunctive testing if lung cancer
48 hours
Complications
Year 1
Extra diagnostic procedure required for final diagnosis.
Intraoperative
Total procedure time
Month 1
Sensitivity and specificity for malignancy

Trial Safety

Safety Estimate

1 of 3

Trial Design

4 Treatment Groups

No Control Group
ROSE with guide sheath

This trial requires 208 total participants across 4 different treatment groups

This trial involves 4 different treatments. Rapid On-site Evaluation (ROSE) is the primary treatment being studied. Participants will be divided into 4 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

ROSE with guide sheath
Procedure
Patients will undergo pEBUS with a regular size bronchoscope using the guide sheath technique and presence of ROSE
Guide sheath without ROSE
Procedure
Patients will undergo pEBUS with a regular size bronchoscope using the guide sheath technique but without ROSE.
No guide sheath without ROSE
Procedure
Patients will undergo pEBUS with a slim bronchoscope combined with a 1.7mm radial probe but no the guide sheath an without the presence of ROSE.
ROSE without guide sheathPatients will undergo pEBUS with a slim bronchoscope combined with a 1.7mm radial probe but no guide sheath and the presence of ROSE.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rapid on-site evaluation (ROSE)
2018
N/A
~800

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months up to 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6 months up to 1 year for reporting.

Closest Location

Health Sciences Centre - Calgary, Canada

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The presence of suspicious mediastinal lymphadenopathy on CT or PET/CT will result in the patient being classified as N1, N2, or N3, regardless of the size of the nodes show original
After discussing the situation with her doctor, the patient decided to go ahead with the bronchoscopy. show original
People who are 18 years or older are adults. show original
The presence of a peripheral pulmonary lesion of ≤5cm on axial CT scan is suggestive of malignancy. show original
The PPL is easily accessible through a small puncture using a bronchoscope, as assessed by an experienced interventional respirologist. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is peripheral pulmonary lesions?

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Pulmonary manifestations are more common in patients with TB than in patients with other TB illnesses. They occur in one in every two of patients with TB. Pulmonary lesions may contribute to the radiologic diagnosis of TB in up to one half of patients with TB.

Unverified Answer

Can peripheral pulmonary lesions be cured?

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In our experience, lung lesions that are smaller than or of unknown size cannot be cured. Larger lesions are likely to shrink. Small lesions can be removed completely with radiologically guided cryoablation.

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What are the signs of peripheral pulmonary lesions?

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The signs of peripheral pulmonary lesions may be either pulmonary symptoms or physical findings. A physical examination of the respiratory system will elicit pulmonary symptoms including shortness of breath, dyspnea, erythema and/or crepitus. These symptoms can reflect radiological findings such as a solitary pulmonary nodule or consolidation.

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What are common treatments for peripheral pulmonary lesions?

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Common treatments for peripheral pulmonary lesions include surgery, radiotherapy, and medication. Patients with peripheral pulmonary lesion have an increased risk of developing a lung cancer and/or a pulmonary metastasis. Follow-up is thus recommended.

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What causes peripheral pulmonary lesions?

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The majority of lung lesions seen on computed tomography screening for lung cancer are not metastatic. Most, however, showed some form of fibrosis or lymphomatous infiltration, which can be from various primary carcinomas, lymphomas, sarcoidosis, or tuberculosis. This is the first report of non-metastatic lesions in the peripheral airways being a cause of unexplained pulmonary lesions on screening CT scan.

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How many people get peripheral pulmonary lesions a year in the United States?

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This is one of the earliest reports on the incidence of lung cancer with a peripheral origin. The incidence exceeds estimates from autopsy data, and suggests that the incidence of lung cancer occurring in the lung periphery is not low, but may be rising.

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What is the average age someone gets peripheral pulmonary lesions?

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Peripheral pulmonary lesions usually occur from occupational exposures to chemical products, pesticides, or dust. The average age (47 yr) can be a good average age to expect the development of lung disease.

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What is the latest research for peripheral pulmonary lesions?

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Until recently, CT and FDG-PET/CT have been the mainstay of imaging in patients with peripheral pulmonary lesions. Now SPECT/CT shows promise and may replace FDG-PET/CT. However, since peripheral pulmonary lesions in patients with lung cancer show poor prognostic factors, it might never be routine.

Unverified Answer

Does rapid on-site evaluation (rose) improve quality of life for those with peripheral pulmonary lesions?

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Recent findings suggests that it is possible to reduce the length of time a patient is waiting in the ED with the implementation of a rapid diagnostic method. This approach is likely to be beneficial to patients by reducing ED delays and thereby improving their quality of life.

Unverified Answer

What is rapid on-site evaluation (rose)?

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Given the high frequency of suspicious lesions at computed radiography in patients with chronic respiratory symptoms, on-site evaluation with rose seems very useful for the detection of small pulmonary nodules.

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Has rapid on-site evaluation (rose) proven to be more effective than a placebo?

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Recent findings of this study suggest that ROSE may be an effective and feasible method to shorten evaluation time in the outpatient setting. There is an advantage to use rapid and efficient diagnostic tests instead of waiting for long times in the clinic.

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What are the common side effects of rapid on-site evaluation (rose)?

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The frequency of on-site complications varied significantly from one evaluation programme to another. These studies highlight the need for good training and standardisation of protocols for on-site evaluations.

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See if you qualify for this trial
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