NCT01169350

Brief Summary

This phase II trial is studying 18F-fluoromisonidazole and fludeoxyglucose F 18 PET/CT scans to see how well they work in assessing oxygen in tumor tissue of patients with soft tissue sarcoma undergoing chemotherapy with or without radiation therapy. Using diagnostic procedures, such as 18F-fluoromisonidazole and fludeoxyglucose F 18 PET scan and CT scan, to find oxygen in tumor cells may help in planning cancer treatment. It may also help doctors predict how well a patient will respond to treatment.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2010

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

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

February 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

November 17, 2017

Completed
Last Updated

November 17, 2017

Status Verified

October 1, 2017

Enrollment Period

1.7 years

First QC Date

July 23, 2010

Results QC Date

June 8, 2017

Last Update Submit

October 17, 2017

Conditions

Recurrent Adult Soft Tissue SarcomaStage I Adult Soft Tissue SarcomaStage II Adult Soft Tissue SarcomaStage III Adult Soft Tissue SarcomaStage IV Adult Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

  • Changes From Baseline Hypoxic Volume (HV)

    ANOVA and Kruskal-Wallis analysis will be performed across the different categories to look for significant associations.

    Baseline and up to 2 years

Secondary Outcomes (3)

  • Overall Survival

    Up to 2 years

  • Disease Free Survival

    From start of treatment to the follow-up review where recurrent disease is first detected, assessed up to 2 years

  • Response to Radiation Therapy (XRT) by RECIST Criteria

    Up to 2 years

Study Arms (1)

Diagnostic (18F FDG and 18F FMISO PET/CT)

EXPERIMENTAL

Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.

Radiation: fludeoxyglucose F 18Other: 18F-fluoromisonidazoleProcedure: positron emission tomographyProcedure: computed tomographyOther: laboratory biomarker analysis

Interventions

fludeoxyglucose F 18RADIATION

Undergo 18F FDG and 18F FMISO PET/CT scans

Diagnostic (18F FDG and 18F FMISO PET/CT)
18F-fluoromisonidazoleOTHER

Undergo 18F FDG and 18F FMISO PET/CT scans

Diagnostic (18F FDG and 18F FMISO PET/CT)
positron emission tomographyPROCEDURE

Undergo 18F FDG and 18F FMISO PET/CT scans

Diagnostic (18F FDG and 18F FMISO PET/CT)
computed tomographyPROCEDURE

Undergo 18F FDG and 18F FMISO PET/CT scans

Diagnostic (18F FDG and 18F FMISO PET/CT)
laboratory biomarker analysisOTHER

Correlative studies

Diagnostic (18F FDG and 18F FMISO PET/CT)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed intermediate- or high-grade soft tissue sarcoma
  • Biopsy proven or highly suspicious primary or recurrent disease
  • Tumor size ≥ 2 cm
  • Scheduled to undergo neoadjuvant chemotherapy with or without radiotherapy
  • Life expectancy ≥ 12 months
  • Negative pregnancy test
  • Willing to undergo PET scanning
  • Willing to undergo possible urinary bladder catheterization (for patients with pelvic or proximal thigh tumors)
  • Able to lie on the imaging table for up to 1.5 hours
  • Weight ≤ 400 lbs
  • Not pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

Fluorodeoxyglucose F18fluoromisonidazoleMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

DeoxyglucoseDeoxy SugarsCarbohydratesSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Results Point of Contact

Title
Dr. Janet F. Eary
Organization
University of Washington
jeary@uw.edu
206-598-6244

Study Officials

  • Janet Eary

    University of Washington

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2010

First Posted

July 26, 2010

Study Start

February 1, 2010

Primary Completion

October 1, 2011

Study Completion

August 1, 2013

Last Updated

November 17, 2017

Results First Posted

November 17, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)