NCT02167204

Brief Summary

This pilot clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET)/computed tomography (CT) in measuring cell proliferation in patients with brain tumors. Comparing results of diagnostic procedures done before, during, and after treatment may help doctors measure tumor growth and plan the best treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

November 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2019

Completed
12 months until next milestone

Results Posted

Study results publicly available

January 13, 2020

Completed
Last Updated

January 13, 2020

Status Verified

December 1, 2019

Enrollment Period

6.2 years

First QC Date

June 16, 2014

Results QC Date

October 28, 2019

Last Update Submit

January 8, 2020

Conditions

Metastatic Malignant Neoplasm in the BrainPrimary Brain NeoplasmRecurrent Brain Neoplasm

Outcome Measures

Primary Outcomes (5)

  • Percentage Change in Measure of FLT Flux

    The percentage change in the kinetic model parameter of FLT flux (Ki) was recorded. Ki is estimated from parameters derived by fitting the FLT input function and the total blood activity curve to the tissue time-activity curve data.

    Baseline to up to 1 year after completion of treatment

  • Percentage Change in Measure of Reflecting Transport

    The percentage change in the kinetic model parameter of FLT transport (K1) was recorded. K1 is defined as the transfer of FLT from blood into tissue (tumor).

    Baseline to up to 1 year after completion of treatment

  • Percentage Change in Measure of Standard Uptake Value

    The percentage change in the maximum standard uptake value (SUVmax) was recorded. SUVmax is defined as the amount of FLT uptake in a lesion.

    Baseline to up to 1 year after completion of treatment

  • Survival

    Time from study entry to death will be recorded

    Up to 7 years

  • Clinical Response Assessed Using Revised Assessment in Neuro-Oncology Criteria

    This is clinical response as assessed at physician discretion using standard of care criteria.

    Up to 7 years

Study Arms (1)

Diagnostic (18F-FLT PET/CT)

EXPERIMENTAL

Patients undergo 18F-FLT PET/CT at baseline (pre-therapy), mid-therapy, completion of therapy, and 1 year after completion of therapy or time of suspected recurrence.

Procedure: Computed TomographyRadiation: Fluorothymidine F-18Procedure: Positron Emission Tomography

Interventions

Computed TomographyPROCEDURE

Undergo 18F-FLT PET/CT

Also known as: CAT, CAT Scan, Computerized Axial Tomography, Computerized Tomography, CT, CT SCAN, tomography
Diagnostic (18F-FLT PET/CT)
Fluorothymidine F-18RADIATION

Undergo 18F-FLT PET/CT

Also known as: 18F-FLT, 3'-Deoxy-3'-(18F) Fluorothymidine, 3'-deoxy-3'-[18F]fluorothymidine, Fluorothymidine F 18
Diagnostic (18F-FLT PET/CT)
Positron Emission TomographyPROCEDURE

Undergo 18F-FLT PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Diagnostic (18F-FLT PET/CT)

Eligibility Criteria

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

You may qualify if:

  • Have a diagnosis or suspected diagnoses of brain tumor (primary, recurrent, or metastatic) by standard clinical diagnosis such as pathology or imaging
  • Planned for treatment with radiation, chemotherapy and surgical resection or any of these treatment strategies combined

You may not qualify if:

  • Inability to provide informed consent
  • Pregnancy
  • Inability to lie still for the imaging study
  • Weight over 350 lbs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

alovudineMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Results Point of Contact

Title
Hannah Linden
Organization
University of Washington
hmlinden@uw.edu
206-606-2053

Study Officials

  • Jason Rockhill

    Fred Hutch/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

June 16, 2014

First Posted

June 18, 2014

Study Start

November 1, 2012

Primary Completion

January 21, 2019

Study Completion

January 21, 2019

Last Updated

January 13, 2020

Results First Posted

January 13, 2020

Record last verified: 2019-12

Locations

US(1)