Diagnosis of Lung Cancer From Exhaled Breath With Silicon Biophotonic Device

NCT01660087 | Withdrawn

• 1 other identifier: SERC/1121480001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The overall objective of this proposal is to develop a non-invasive, inexpensive and accurate device that detects VOCs in exhaled breath for lung cancer screening. Toward this goal, the team will design and fabricate a biophotonic platform consists of arrays of silicon micro-ring resonator sensors coated with polymers with different organic functionalities, in which each sensor is widely responsive to a variety of VOCs for the detection of lung cancer by means of breath testing. The team will identify signature VOCs as lung cancer biomarkers by comparison VOC contents between alveolar gas that directly sampled from the nodule or mass and exhaled breath using gas chromatography/ mass spectrometry. The specific aims of this proposal are as followings: Aim 1: To develop a biophotonic platform for the detection of VOCs Aim 2: To achieve multiplex detection of VOCs with high sensitivity and specificity using a novel biophotonic device. Aim 3: To evaluate the device as a lung cancer screening tool by testing both healthy and lung cancer breath samples

Conditions

Lung Cancer

Keywords

Exhaled breath condensate (EBC) method; Volatile Organic Compounds (VOCs); Endobronchial Ultrasound (EBUS); Confocal Endoscopy; Exhaled alveolar gas

Outcome Measures

Primary Outcomes (1)

• Identification of signature VOCs as ling cancer biomarkers by comparing VOC contents between alveolar gas from lung nodules and exhaled gas.

Interventions

Biophotonic platform for VOC detection DEVICE

Multiplex detection of VOCs with high sensitivity and specificity using a novel biophotonic device.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients aged above 21 years, capable of giving consent and suspected of lung cancer with radiological lung nodules and masses.

You may not qualify if:

• Patients with contra-indications to bronchoscopy and CT-TTNA that include active myocardial ischemia, uncorrected coagulopathy, severe respiratory distress, uncontrollable cough, and pregnancy will be excluded. Before females in the reproductive age are recruited, urine pregnancy test will be performed and confirmed negative.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (2)

Institute of Microelectronics

Singapore, Singapore, 117685, Singapore

Location

National University Hospital/ National University of Singapore

Singapore, Singapore, 119074, Singapore

Location

Related Publications (15)

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MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pyng Lee, MD

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

• Mi Kyoung Park, Ph.D

  Institute of Microelectronics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2012
• First Posted: August 8, 2012
• Study Start: April 1, 2012
• Primary Completion: September 30, 2015
• Study Completion: September 30, 2015
• Last Updated: April 18, 2017

Record last verified: 2017-04

Locations

SG (2)