Deuterated Phenanthrene Tetraol in Smokers Who Are at High Risk For Lung Cancer

Correlation of [D10] Phenanthrene Metabolism With Bronchoepithelial Dysplasia and Metaplasia in Smokers at High Risk for Lung Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01673711

Enrollment

350

Registered

2012-08-28

Start date

2012-07-31

Completion date

2019-09-30

Last updated

2019-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Squamous Lung Dysplasia, Tobacco Use Disorder

Brief summary

This clinical trial studies deuterated phenanthrene tetraol in smokers who are at high risk for lung cancer. Studying samples of urine in the laboratory from smokers who are at high risk for lung cancer may help doctors learn more about biomarkers related to cancer.

Detailed description

PRIMARY OBJECTIVES: I. To determine the relationship between urinary deuterated (\[D10\]) phenanthrene tetraol (PheT) level, PheT:phenanthrols (HOPhe) ratio, and the presence of bronchoepithelial metaplasia and/or dysplasia in smokers who have undergone screening bronchoscopy at Roswell Park Cancer Institute (RPCI). OUTLINE: Patients receive deuterated phenanthrene tetraol orally (PO). Urine samples are collected for laboratory studies for 6 hours after dosing.

Interventions

DRUGdeuterated phenanthrene tetraol

Given PO

DRUGpharmacological study

Correlative studies

DRUGlaboratory biomarker analysis

Correlative studies

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Current or former smoker * 18 years of age or older * Documentation of a diagnosis of no dysplasia, dysplasia, or metaplasia on bronchoscopy (white light and/or autofluorescence) conducted less than or equal to 10 years prior to registration * Not pregnant or breastfeeding * Able to provide written informed consent indicating an understanding of the nature of the study * Willing to comply with study requirements, including taking \[D10\]phenanthrene in water with 20% ethanol * No previous history of aerodigestive cancer * Not currently undergoing treatment for any cancers. Exception: basal cell or squamous cell skin cancer * Not currently taking any other investigational agents * No history of allergic reaction to \[D10\]phenanthrene or similar compounds * No major medical comorbidities, for example, renal dysfunction, heart function, and diabetes, to be adjudicated by study physicians * Not a former or recovering alcoholic * No use of metronidazole or antabuse less than or equal to 7 days prior to \[D10\]phenanthrene dosing, as they could potentially interact with ethanol

Design outcomes

Primary

Measure	Time frame	Description
Urinary deuterated phenanthrene tetraol level	Up to 6 hours	A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of chronic obstructive pulmonary disease (COPD) or asbestos, duration of smoking, smoking intensity, age, and gender.
PheT:HOPhe ratio	Up to 6 hours	A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of COPD or asbestos, duration of smoking, smoking intensity, age, and gender.
Correlation of deuterated phenanthrene tetraol level and PheT:HOPhe ratio with the presence of bronchoepithelial metaplasia and/or dysplasia	Up to 6 hours	A multiple regression analysis will be performed including explanatory variables such as lesion status, presence/absence of COPD or asbestos, duration of smoking, smoking intensity, age, and gender.

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026