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Fluorothymidine F-18 PET in Diagnosing Patients With Intermediate or High Grade Soft Tissue Sarcoma

Primary Purpose

Stage II Adult Soft Tissue Sarcoma, Stage IIA Adult Soft Tissue Sarcoma, Stage IIB Adult Soft Tissue Sarcoma

Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Fluorothymidine F-18
Laboratory Biomarker Analysis
Positron Emission Tomography
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stage II Adult Soft Tissue Sarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Diagnostic (fluorothymidine F-18 PET)

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Change in Fluorothymidine F-18 peak SUV as response to therapy
    Measured by peak SUV value 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.
    Fluorothymidine F-18 mean SUV correlation with pathology mitotic index
    Measured as Ki-67. Will assess the mitotic index of resection tissue. Spearman's correlation coefficient will be computed to assess the association between the mitotic index and fluorothymidine F-18 uptake parameters in post-radiation scans.
    Fluorothymidine F-18 peak SUV correlation with pathology mitotic index
    Measured as Ki-67. Will assess the mitotic index of resection tissue. Spearman's correlation coefficient will be computed to assess the association between the mitotic index and fluorothymidine F-18 uptake parameters in post-radiation scans.
    Fluorothymidine F-18 peak SUV correlation with enhancement by MRI
    Measured as Ki-67. Evaluated by the standard of care magnetic resonance imaging. Will assess the size and location of irregularly increased T2-weighted signal intensity. Descriptive statistical analysis will be conducted
    Volume of T2 enhanced MRI
    Measured in (cm3).

    Full Information

    First Posted
    January 23, 2018
    Last Updated
    June 4, 2020
    Sponsor
    OHSU Knight Cancer Institute
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03613259
    Brief Title
    Fluorothymidine F-18 PET in Diagnosing Patients With Intermediate or High Grade Soft Tissue Sarcoma
    Official Title
    A Pilot Study Investigating ¹⁸F-FLT-PET as a Marker of Response to Preoperative Radiotherapy in Soft Tissue Sarcoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Funding expired
    Study Start Date
    June 1, 2020 (Anticipated)
    Primary Completion Date
    June 1, 2022 (Anticipated)
    Study Completion Date
    June 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    OHSU Knight Cancer Institute
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    PRIMARY OBJECTIVES: I. To determine fluorothymidine F-18 (¹⁸F-FLT) uptake parameters before and after radiotherapy. SECONDARY OBJECTIVES: I. To correlate ¹⁸F-FLT uptake post-radiotherapy scan with pathologic response. II. To correlate levels the mitotic index in surgical specimens with the ¹⁸F-FLT uptake in post-radiation scans. III. To correlate ¹⁸F-FLT uptake both pre- and post-radiotherapy with magnetic resonance imaging (MRI) enhancement both within and around the tumor. TERTIARY OBJECTIVES: I. To compare ¹⁸F-FLT uptake and fludeoxyglucose F-18 (FDG) uptake when FDG-PET-computed tomography (CT) is available, pre-radiation, post-radiation, or both. II. To compare ¹⁸F-FLT uptake in post-radiation scans with local recurrences looking for spatial correlation. OUTLINE: Patients receive fluorothymidine F-18 intravenously (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. After completion of study, patients are followed up for 2 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stage II Adult Soft Tissue Sarcoma, Stage IIA Adult Soft Tissue Sarcoma, Stage IIB Adult Soft Tissue Sarcoma, Stage IIC Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Diagnostic (fluorothymidine F-18 PET)
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Fluorothymidine F-18
    Other Intervention Name(s)
    ¹⁸F-FLT, 3'-deoxy-3'-(¹⁸F) fluorothymidine, 3'-deoxy-3'-[¹⁸F]fluorothymidine, fluorothymidine F 18
    Intervention Description
    Given IV
    Intervention Type
    Other
    Intervention Name(s)
    Laboratory Biomarker Analysis
    Intervention Description
    Correlative studies
    Intervention Type
    Procedure
    Intervention Name(s)
    Positron Emission Tomography
    Other Intervention Name(s)
    Medical Imaging, Positron Emission Tomography, PET, PET Scan, positron emission tomography scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging
    Intervention Description
    Undergo fluorothymidine F-18 PET
    Primary Outcome Measure Information:
    Title
    Change in Fluorothymidine F-18 mean standardized uptake value (SUV) as response to therapy.
    Description
    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.
    Time Frame
    Pre (=< 21 days before radiation) and Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography
    Secondary Outcome Measure Information:
    Title
    Change in Fluorothymidine F-18 peak SUV as response to therapy
    Description
    Measured by peak SUV value 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.
    Time Frame
    Pre (=< 21 days before radiation) and Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography
    Title
    Fluorothymidine F-18 mean SUV correlation with pathology mitotic index
    Description
    Measured as Ki-67. Will assess the mitotic index of resection tissue. Spearman's correlation coefficient will be computed to assess the association between the mitotic index and fluorothymidine F-18 uptake parameters in post-radiation scans.
    Time Frame
    Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography
    Title
    Fluorothymidine F-18 peak SUV correlation with pathology mitotic index
    Description
    Measured as Ki-67. Will assess the mitotic index of resection tissue. Spearman's correlation coefficient will be computed to assess the association between the mitotic index and fluorothymidine F-18 uptake parameters in post-radiation scans.
    Time Frame
    Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography
    Title
    Fluorothymidine F-18 peak SUV correlation with enhancement by MRI
    Description
    Measured as Ki-67. Evaluated by the standard of care magnetic resonance imaging. Will assess the size and location of irregularly increased T2-weighted signal intensity. Descriptive statistical analysis will be conducted
    Time Frame
    Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography
    Title
    Volume of T2 enhanced MRI
    Description
    Measured in (cm3).
    Time Frame
    Pre (=< 21 days before radiation) and Post (=< 14 days before resection) radiation fluorothymidine F-18 positron emission tomography

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Arthur Y Hung, MD
    Organizational Affiliation
    OHSU Knight Cancer Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Fluorothymidine F-18 PET in Diagnosing Patients With Intermediate or High Grade Soft Tissue Sarcoma

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