NCT00585741

Brief Summary

Fractionated radiotherapy induces an observable change in the proliferative activity as assessed by pre-treatment and early-treatment 18F-FLT PET imaging. This study is designed to investigate 18F-FLT as a PET imaging agent for predicting treatment effectiveness in several tumors and will serve as a pilot study to a planned PO1 submission

Trial Health

57
Monitor

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 Dec 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

December 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 3, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

February 23, 2012

Status Verified

February 1, 2012

Enrollment Period

5 years

First QC Date

December 21, 2007

Last Update Submit

February 22, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • To test whether the cellular response to fractionated radiotherapy leads to observable global change in the uptake of 18F-FLT as assessed by PET imaging

    end of study

Secondary Outcomes (1)

  • To assess the technical and logistic feasibility of 18F-FLT scans in a population of cancer patients

    end of study

Study Arms (5)

2. Head and neck

EXPERIMENTAL

Imaging with 18F-FLT PET

Procedure: Imaging with 18F-FLT PET

3. Lung

EXPERIMENTAL

Imaging with 18F-FLT PET

Procedure: Imaging with 18F-FLT PET

4. prostate

EXPERIMENTAL

Imaging with 18F-FLT PET

Procedure: Imaging with 18F-FLT PET

5. esophagus

EXPERIMENTAL

Imaging with 18F-FLT PET

Procedure: Imaging with 18F-FLT PET

1.CNS

EXPERIMENTAL

Imaging with 18F-FLT PET

Procedure: Imaging with 18F-FLT PET

Interventions

Imaging with 18F-FLT PET

1.CNS

Eligibility Criteria

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

You may qualify if:

  • Able to tolerate a PET/CT scan
  • Age of 18 or older
  • signed informed consent
  • being considered for radiotherapy for treatment of CNS mets, Head and neck cancer, lung cancer, prostate cancer or esophageal cancer

You may not qualify if:

  • Prior XRT to site being studied
  • severe claustrophobia or inability to tolerate PET/CT
  • unable to provide written consent
  • pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Hospital and clinis

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsLung NeoplasmsProstatic NeoplasmsEsophageal Neoplasms

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Robert Jeraj, Ph.D.

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 3, 2008

Study Start

December 1, 2006

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

February 23, 2012

Record last verified: 2012-02

Locations