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WithdrawnNot applicableNCT00784329
Official study title

Pilot Study To Evaluate Optical Frequency Domain Imaging For Diagnosis Of Central Airway Disease

Study summary

To evaluate the potential of a new imaging device, termed Optical Frequency Domain Imaging (OFDI), in the early diagnosing of pulmonary malignancies in the central airways.

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Key things to know

Main goalDiagnostic

This describes the study’s primary purpose.

What is being studiedOptical Frequency Domain Imaging (OFDI) System

The study team can explain what participation involves.

Who it may be forSquamous Cell Lung Cancer · Lung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 12, 2019 · Source: ClinicalTrials.gov

Is enrollment open?Withdrawn

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Lahey Clinic

Study sponsor

01
Study overview

What this study is about

Purpose
Diagnostic
Study type
Interventional
Phase
Not applicable
Sponsor
Lahey Clinic
Interventions being studied
Device: Optical Frequency Domain Imaging (OFDI) System
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Patients undergoing bronchoscopy for known or suspected pulmonary malignancy in the central airways
  • Patients must be over the age of 18
  • Patient must be able to give informed consent
  • Women with child bearing potential must have a negative pregnancy test within seven days prior to the procedure
Reasons someone may not be able to joinExclusion criteria
  • PaO2 less than 80 on FiO2 greater 70%
  • Systolic blood pressure less than 90
  • Active bronchospasm
  • INR greater than 2.0 (INR: International Normalized Ratio)
  • Recent myocardial infarction within last two weeks
  • Active cardiac chest pain
  • Significant untreated sleep apnea
  • FEV1 less than 30% of predicted (FEV1: forced expiratory volume in 1 second)
  • Worsening hypercarbia with PaCO2 greater than 55
  • In active respiratory failure (unless endotracheal intubation is performed first to stabilize the airway)

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Lahey Clinic, Inc.Burlington, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 12, 2019. Always confirm current availability with the study team.

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