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FMISO PET/CT Imaging Trial for Assessing Hypoxia in Soft Tissue Sarcomas

Primary Purpose

Soft Tissue Sarcoma

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
18F-FMISO
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Soft Tissue Sarcoma

Eligibility Criteria

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

Inclusion Criteria:

  1. Known or suspected soft tissue sarcoma seen on at least one type of standard imaging (e.g. CT, ultrasound, MRI, or 18F-FDG PET/CT)
  2. At least 18 years of age
  3. Subjects with local disease or advanced/metastatic disease will be eligible
  4. Willing to consent to use of tissue from biopsy or surgery for the purposes of this study
  5. Participants must be informed of the investigational nature of this study and be willing and able to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.

Exclusion Criteria:

  1. Females who are pregnant at the time of screening will not be eligible for this study; a urine pregnancy test will be performed at screening in women of child-bearing potential
  2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician
  3. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

18F-MISO PET/CT Test Retest

18F-MISO PET/CT

Arm Description

Up to 5 of the 30 intended subjects will participate in a test-retest group that will undergo a second 18F-FMISO scan. Subjects will undergo biopsy as part of their clinical care. Subjects will be asked to consent to allow archived excess tissue to be accessed for the purposes of this study

The investigators anticipate enrolling up to 30 subjects who will undergo 18F-FMISO PET/CT.Subjects will undergo biopsy as part of their clinical care. Subjects will be asked to consent to allow archived excess tissue to be accessed for the purposes of this study

Outcomes

Primary Outcome Measures

Hypoxia in FMISO PET/CT
In vivo measures of hypoxia as measured by PET/CT hypoxia tracer (18F-MISO) uptake with PLOD2 expression levels obtained using qRT-PCR in subjects with STS and to identify hypoxia tracer uptake threshold values for in vivo hypoxia based on PLOD2 expression levels

Secondary Outcome Measures

Marker of STS Hypoxia
hypoxia tracer uptake as a marker of STS hypoxia by assessing how in vivo tracer (18F-MISO) T/M uptake ratios correlate with in vitro markers of hypoxia (including HIF-1α, and CAIX) obtained from immunohistochemistry
Relationship of sarcoma hypoxia to glycolysis
The relationship of sarcoma hypoxia to glycolysis using a PET/CT hypoxia tracer (18F-MISO) tumor-to-muscle (T/M) uptake ratios compared to the maximum standardized uptake values (SUVmax) obtained from 18F-FDG PET/CT
Predictors of in vitro PLOD2 expression levels
Best predictors of in vitro PLOD2 expression levels using a PET/CT hypoxia tracer (18F-MISO) and 18F-F-FDG PET/CT uptake values, including HIF-1α and CAIX, and other hypoxia markers.

Full Information

First Posted
October 31, 2018
Last Updated
March 15, 2021
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03730077
Brief Title
FMISO PET/CT Imaging Trial for Assessing Hypoxia in Soft Tissue Sarcomas
Official Title
Integrated Biomarker PET/CT Imaging Trial for Assessing Hypoxia in Soft Tissue Sarcomas Using a Novel PET/CT Tracer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
PI Left Institution
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
February 18, 2021 (Actual)
Study Completion Date
February 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

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

5. Study Description

Brief Summary
Subjects with known or suspected primary soft tissue sarcoma of the extremities may be eligible for this study. Subjects may participate in this study if they are at least 18 years of age. Most participants will be receiving care at the clinical practices of the University of Pennsylvania Health System. Positron emission tomography (PET/CT) imaging will be used to evaluate soft tissue sarcoma hypoxia using an investigational radiotracer, 18F-FMISO Subjects will also undergo an 18F-FDG PET/CT scan close to the time of their initial hypoxia PET/CT to compare in vivo measures of hypoxia to 18F-FDG uptake. The FDG PET/CT may be performed as part of standard clinical care or as a research scan. Both PET/CT scans will occur prior to starting new therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18F-MISO PET/CT Test Retest
Arm Type
Experimental
Arm Description
Up to 5 of the 30 intended subjects will participate in a test-retest group that will undergo a second 18F-FMISO scan. Subjects will undergo biopsy as part of their clinical care. Subjects will be asked to consent to allow archived excess tissue to be accessed for the purposes of this study
Arm Title
18F-MISO PET/CT
Arm Type
Experimental
Arm Description
The investigators anticipate enrolling up to 30 subjects who will undergo 18F-FMISO PET/CT.Subjects will undergo biopsy as part of their clinical care. Subjects will be asked to consent to allow archived excess tissue to be accessed for the purposes of this study
Intervention Type
Drug
Intervention Name(s)
18F-FMISO
Intervention Description
18F-FMISO PET/CT
Primary Outcome Measure Information:
Title
Hypoxia in FMISO PET/CT
Description
In vivo measures of hypoxia as measured by PET/CT hypoxia tracer (18F-MISO) uptake with PLOD2 expression levels obtained using qRT-PCR in subjects with STS and to identify hypoxia tracer uptake threshold values for in vivo hypoxia based on PLOD2 expression levels
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Marker of STS Hypoxia
Description
hypoxia tracer uptake as a marker of STS hypoxia by assessing how in vivo tracer (18F-MISO) T/M uptake ratios correlate with in vitro markers of hypoxia (including HIF-1α, and CAIX) obtained from immunohistochemistry
Time Frame
2 years
Title
Relationship of sarcoma hypoxia to glycolysis
Description
The relationship of sarcoma hypoxia to glycolysis using a PET/CT hypoxia tracer (18F-MISO) tumor-to-muscle (T/M) uptake ratios compared to the maximum standardized uptake values (SUVmax) obtained from 18F-FDG PET/CT
Time Frame
2 years
Title
Predictors of in vitro PLOD2 expression levels
Description
Best predictors of in vitro PLOD2 expression levels using a PET/CT hypoxia tracer (18F-MISO) and 18F-F-FDG PET/CT uptake values, including HIF-1α and CAIX, and other hypoxia markers.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Known or suspected soft tissue sarcoma seen on at least one type of standard imaging (e.g. CT, ultrasound, MRI, or 18F-FDG PET/CT) At least 18 years of age Subjects with local disease or advanced/metastatic disease will be eligible Willing to consent to use of tissue from biopsy or surgery for the purposes of this study Participants must be informed of the investigational nature of this study and be willing and able to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures. Exclusion Criteria: Females who are pregnant at the time of screening will not be eligible for this study; a urine pregnancy test will be performed at screening in women of child-bearing potential Inability to tolerate imaging procedures in the opinion of an investigator or treating physician Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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FMISO PET/CT Imaging Trial for Assessing Hypoxia in Soft Tissue Sarcomas

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