LesionNCT03376971
Real-Time Optical Biopsy in Improving Lung Cancer Diagnosis in Patients Undergoing Lung Biopsy
A study testing Biopsy and Laboratory Biomarker Analysis in people with Lesion and Lung Cancer, run by University of Arizona at 1 site in United States.
Trial summary
This pilot early phase I trial studies how well real-time optical biopsy works in improving lung cancer diagnosis in patients undergoing lung biopsy. Real-time optical biopsy using confocal microscopy may improve the ability of physicians to diagnose lung cancer and accurately differentiate cancerous and benign… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lesion, Lung Cancer, Diagnoses Disease
- What is being tested?
- Biopsy and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2017to 26 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be drawn from the pool of patients who have suspicious lesions identified on CT and who are already scheduled for a lung biopsy procedure with Dr. Woodhead or one of his colleagues
- Patients will be asked to consent to 2 to 3 extra biopsy samples to be used for this research project
Who cannot join
- Excluded from this study will be minors below age 18, prisoners, pregnant women, patients with a contraindication for additional lung biopsies, and patients who cannot give informed consent (language barrier, cognitive impairment, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-Time Optical Biopsy for Improved Lung Cancer Diagnosis
This pilot early phase I trial studies how well real-time optical biopsy works in improving lung cancer diagnosis in patients undergoing lung biopsy. Real-time optical biopsy using confocal microscopy may improve the ability of physicians to diagnose lung cancer and accurately differentiate cancerous and benign lesions found during computed tomography screening.
Read the detailed description
PRIMARY OBJECTIVES:
- Show that it is possible to distinguish lung cancer from benign lesions in ex vivo tissue samples using optical microscopy.
II. Test a proof-of-concept endoscopic instrument for imaging through a biopsy needle under computed tomography (CT) guidance on ex vivo tissue samples.
OUTLINE:
Patients undergo extraction of up to 3 additional lung biopsies from target lesions that are at least 2-3 cm in diameter using the 19 gauge SuperCore biopsy needle or the 20 gauge Rotax needle. The extracted tissue is imaged via confocal fluorescence microscopy using a variety of fluorescent contrast agents, such as, fluorescein sodium, methylene blue, or indocyanine green and then undergo hematoxylin and eosin processing.
- Conditions
- Lesion, Lung Cancer, Diagnoses Disease
- Being tested
- Biopsy, Laboratory Biomarker Analysis
- Keywords
- Lesion, Lung, Cancer, Diagnosis, Optical Biopsy, Biopsy
- Medical subject headings
- Lung Neoplasms, Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Also called Bx
Undergo lung biopsy
Laboratory Biomarker AnalysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (lung biopsy) | Experimental | Patients undergo extraction of up to 3 additional lung biopsies from target lesions that are at least 2-3 cm in diameter using the 19 gauge SuperCore biopsy needle or the 20 gauge Rotax needle. The extracted tissue is imaged via confocal fluorescence microscopy using a variety of fluorescent contrast agents, such as fluorescein sodium, methylene blue, indocyanine green and then undergo hematoxylin and eosin processing. Receives: Procedure: Biopsy; Other: Laboratory Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of ex vivo tissue samples for lung cancer or benign lesions using optical microscopy
The aim is to show that it is possible to distinguish lung cancer from benign lesions in ex vivo tissue samples using optical microscopy.
Measured: At the time of biopsy
Imaging of ex vivo tissue samples using an endoscopic instrument
A proof-of-concept endoscopic instrument will be tested for imaging through a biopsy needle under computed tomography guidance on ex vivo tissue samples.
Measured: At the time of biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start26 Jul 2017
- Primary completion26 Apr 2022
- Study completion26 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LesionStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Rouse, PhD, Principal investigator, The University of ArizonaGregory Woodhead, MD, Principal investigator, The University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376971
- Sponsor's protocol ID
- 1706540415
- Other IDs
- 1706540415
- Status last verified
- Sep 2024
- First submitted
- 13 Dec 2017
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Optical Biopsy for Improved Lung Cancer Diagnosis
- ClinicalTrials.gov ID
- NCT03376971
- Acronym / sponsor ID
- 1706540415
- Conditions
- Lesion, Lung Cancer, Diagnoses Disease
- Keywords
- Lesion, Lung, Cancer, Diagnosis, Optical Biopsy, Biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 26 Apr 2022 (actual)
- Study completion
- 26 Apr 2022 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot early phase I trial studies how well real-time optical biopsy works in improving lung cancer diagnosis in patients undergoing lung biopsy. Real-time optical biopsy using confocal microscopy may improve the ability of physicians to diagnose lung cancer and accurately differentiate cancerous and benign lesions found during computed tomography screening.
Detailed description
PRIMARY OBJECTIVES:
- Show that it is possible to distinguish lung cancer from benign lesions in ex vivo tissue samples using optical microscopy.
II. Test a proof-of-concept endoscopic instrument for imaging through a biopsy needle under computed tomography (CT) guidance on ex vivo tissue samples.
OUTLINE:
Patients undergo extraction of up to 3 additional lung biopsies from target lesions that are at least 2-3 cm in diameter using the 19 gauge SuperCore biopsy needle or the 20 gauge Rotax needle. The extracted tissue is imaged via confocal fluorescence microscopy using a variety of fluorescent contrast agents, such as, fluorescein sodium, methylene blue, or indocyanine green and then undergo hematoxylin and eosin processing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (lung biopsy) | Experimental | Procedure: Biopsy, Other: Laboratory Biomarker AnalysisPatients undergo extraction of up to 3 additional lung biopsies from target lesions that are at least 2-3 cm in diameter using the 19 gauge SuperCore biopsy needle or the 20 gauge Rotax needle. The extracted tissue is imaged via confocal fluorescence microscopy using a variety of fluorescent contrast agents, such as fluorescein sodium, methylene blue, indocyanine green and then undergo hematoxylin and eosin processing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants will be drawn from the pool of patients who have suspicious lesions identified on CT and who are already scheduled for a lung biopsy procedure with Dr. Woodhead or one of his colleagues
- Patients will be asked to consent to 2 to 3 extra biopsy samples to be used for this research project
Key exclusion criteria (1 listed)
- Excluded from this study will be minors below age 18, prisoners, pregnant women, patients with a contraindication for additional lung biopsies, and patients who cannot give informed consent (language barrier, cognitive impairment, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiopsyAlso: BxUndergo lung biopsy | Procedure or surgery | Diagnostic (lung biopsy) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Diagnostic (lung biopsy) |
Primary outcome
Diagnosis of ex vivo tissue samples for lung cancer or benign lesions using optical microscopy
Time frame: At the time of biopsy
The aim is to show that it is possible to distinguish lung cancer from benign lesions in ex vivo tissue samples using optical microscopy.
Imaging of ex vivo tissue samples using an endoscopic instrument
Time frame: At the time of biopsy
A proof-of-concept endoscopic instrument will be tested for imaging through a biopsy needle under computed tomography guidance on ex vivo tissue samples.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Rouse, PhD principal investigator
The University of Arizona
Gregory Woodhead, MD principal investigator
The University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biopsy and Laboratory Biomarker Analysis in people with Lesion and Lung Cancer, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis of ex vivo tissue samples for lung cancer or benign lesions using optical microscopy (time frame: At the time of biopsy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.