NCT00380666

Brief Summary

The trial evaluates the utility of 18FDG-PET/CT scan in the target definition process when SBRT is planned for stage I NSCLC.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2007

Status
withdrawn

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

First Submitted

Initial submission to the registry

September 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2006

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

3.1 years

First QC Date

September 25, 2006

Last Update Submit

May 4, 2021

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Concordance indices between CT-based and PET/CT-based target definitions versus volumes of surgical specimens

    1 month

Secondary Outcomes (1)

  • Intra- and inter-individual variability of target definition

    1 month

Study Arms (1)

PET/CT defined target

OTHER

Target defined by use of fluoro-deoxy-glucose (FDG)-PET/CT scan for planning af stereotactic radiotherapy.

Procedure: PET/CT scan

Interventions

PET/CT scanPROCEDURE
PET/CT defined target

Eligibility Criteria

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

You may qualify if:

  • Age 18 years or above
  • Histologically or cytologically verified NSCLC
  • Disease stage I (T1-2 N0 M0)
  • Referred from the multi-disciplinary lung cancer conference at Aarhus University Hospital for operation at Skejby Hospital, Aarhus University Hospital
  • Oral and written informed consent

You may not qualify if:

  • Medically treated diabetes mellitus
  • Fasting blood-glucoses above 6,7 mM
  • Blood-creatinin above normal
  • Allergies to intravenous contrast
  • Detention according to the Danish laws on psychiatrics that does not comply with participation in a clinical trial
  • Employment at the Dept. of Oncology, Aarhus University Hospital
  • Pregnancy
  • Lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

  • Morten Hoyer, MD, PhD

    Aarhus University Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

September 25, 2006

First Posted

September 26, 2006

Study Start

June 1, 2007

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

May 6, 2021

Record last verified: 2021-05