NCT03613259

Brief Summary

This pilot early phase I trial studies how well fluorothymidine F-18 positron emission tomography (PET) works in imaging patients with intermediate or high grade soft tissue sarcoma. Fluorothymidine F-18 PET may provide useful information about the tumor's response to treatment and may give the doctors early results that would better help to plan the post-surgical therapy.

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 2020

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withdrawn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

January 23, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

2 years

First QC Date

January 23, 2018

Last Update Submit

June 4, 2020

Conditions

Stage II Adult Soft Tissue SarcomaStage IIA Adult Soft Tissue SarcomaStage IIB Adult Soft Tissue SarcomaStage IIC Adult Soft Tissue SarcomaStage III Adult Soft Tissue SarcomaStage IV Adult Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

  • Change in Fluorothymidine F-18 mean standardized uptake value (SUV) as response to therapy.

    Measured by mean SUV where the response to therapy is Pathological Response Disease change in volume of tumor (in cm3) utilizing Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) with magnetic resonance imaging (MRI). Mean, median, standard deviation, and range will be reported for continuous variables. Box plot, histogram plot, and density plot may be used to graphically show the distribution of the continuous endpoints.

    Pre (=< 21 days before radiation) and Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography

Secondary Outcomes (5)

  • Change in Fluorothymidine F-18 peak SUV as response to therapy

    Pre (=< 21 days before radiation) and Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography

  • Fluorothymidine F-18 mean SUV correlation with pathology mitotic index

    Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography

  • Fluorothymidine F-18 peak SUV correlation with pathology mitotic index

    Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography

  • Fluorothymidine F-18 peak SUV correlation with enhancement by MRI

    Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography

  • Volume of T2 enhanced MRI

    Pre (=< 21 days before radiation) and Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography

Study Arms (1)

Diagnostic (fluorothymidine F-18 PET)

EXPERIMENTAL

Patients receive fluorothymidine F-18 IV over 1 minute and undergo PET scan over 60 minutes 21 or less days prior to standard of care radiation therapy and 14 or less days prior to the standard of care surgery.

Drug: Fluorothymidine F-18Other: Laboratory Biomarker AnalysisProcedure: Positron Emission Tomography

Interventions

Fluorothymidine F-18DRUG

Given IV

Also known as: ¹⁸F-FLT, 3'-deoxy-3'-(¹⁸F) fluorothymidine, 3'-deoxy-3'-[¹⁸F]fluorothymidine, fluorothymidine F 18
Diagnostic (fluorothymidine F-18 PET)
Laboratory Biomarker AnalysisOTHER

Correlative studies

Diagnostic (fluorothymidine F-18 PET)
Positron Emission TomographyPROCEDURE

Undergo fluorothymidine F-18 PET

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, positron emission tomography scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
Diagnostic (fluorothymidine F-18 PET)

Eligibility Criteria

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

You may qualify if:

  • Participants must have histological evidence of an intermediate or high grade soft tissue sarcoma (STS) of any stage
  • Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as \>= 1 cm with CT scan or MRI
  • Prior resection is allowed if there is measurable gross disease and the subject plans to have neoadjuvant radiotherapy followed by resection
  • Eastern Cooperative Oncology Group (ECOG) performance status =\< 4, Karnofsky performance status \>= 40%
  • Creatinine =\< 3 x upper limit of normal (ULM)
  • Blood urea nitrogen (BUN) =\< 3 x ULN
  • Participants should be willing and able to have both PET-CT scans
  • Participants should be eligible for and plan to undergo neoadjuvant radiation therapy and should be seen by a radiation oncologist prior to beginning the study; radiation at an outside facility will be allowed
  • Participants should be eligible for and plan to have resection with a surgeon specializing in STS at Oregon Health and Science University (OHSU) and should be seen by said surgeon prior to beginning the study
  • Participants should have a life expectancy that is greater than the study duration
  • Participants should be willing to use adequate contraception from the time of the first PET-CT scan to 2 months after radiotherapy finishes; should a woman become pregnant while participating in this study, she should inform her treating physician immediately
  • Women with childbearing potential must have a negative pregnancy test before each PET-CT scan
  • Participants should have the ability to understand and the willingness to sign a written informed consent document
  • Participants must sign a study specific consent form prior to registration

You may not qualify if:

  • Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or significant inflammation at treatment site or psychiatric illness/social situations that would limit compliance with study requirements or whose lab values do not meet the criteria above are excluded
  • Pregnant women are excluded from this study
  • Breast feeding women are excluded from this study
  • Patients receiving chemotherapy during the course of radiation are excluded
  • Patients whose weights exceed the tolerance of the table are excluded; the weight limit at OHSU is 450 pounds (lbs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sarcoma

Interventions

alovudineMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Arthur Y Hung, MD

    OHSU Knight Cancer Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 23, 2018

First Posted

August 3, 2018

Study Start

June 1, 2020

Primary Completion

June 1, 2022

Study Completion

June 1, 2022

Last Updated

June 9, 2020

Record last verified: 2020-06