NCT00246116

Brief Summary

For this companion protocol, we intend to make an assessment of both tumor response and local tissue effects. Patients undergoing the correlative investigation will be a subset of the patients already enrolled on the phase II study.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2002

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 31, 2005

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

February 11, 2022

Status Verified

January 1, 2022

Enrollment Period

9.4 years

First QC Date

October 28, 2005

Last Update Submit

January 28, 2022

Conditions

Non-small-cell Lung Cancer

Keywords

Lung CancerRadiation OncologyTreated with Stereostatic Body Radiation

Outcome Measures

Primary Outcomes (1)

  • To characterize the effect of treatment on tumor metabolic activity as a function of time.

    5 years from enrollment

Secondary Outcomes (1)

  • To correlate the first two objectives with outcome objectives of the clinical phase II protocol (survival, local control, and toxicity) in order to assess the ultimate utility of these imaging assessments in this patient population.

    5 years from completion of enrollment

Interventions

Functional Imaging of Treatment EffectsPROCEDURE

PET \& VQ Scans

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients consented, eligible, and scheduled to be treated on the phase II study of extracranial stereotactic radioablation (a.k.a stereotactic body radiotherapy) for early stage lung cancer already approved at Indiana University

You may not qualify if:

  • Patients with contraindications to functional imaging (e.g. allergy to agent used in studies) and patient unwilling to fulfill requirements of both protocols are ineligible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungLung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ronald McGarry, MD

    Indiana University - Department of Radiation Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2005

First Posted

October 31, 2005

Study Start

February 1, 2002

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

February 11, 2022

Record last verified: 2022-01