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

Integrated Biomarker PET/CT Imaging Trial for Assessing Hypoxia in Soft Tissue Sarcomas Using a Novel PET/CT Tracer

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.

Study Overview

• Status: Terminated
• Conditions: Soft Tissue Sarcoma
• Intervention / Treatment: Drug: 18F-FMISO

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 18F-MISO PET/CT Test Retest; 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	Drug: 18F-FMISO; 18F-FMISO PET/CT
Experimental: 18F-MISO PET/CT; 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	Drug: 18F-FMISO; 18F-FMISO PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years
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	2 years
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.	2 years

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): February 18, 2021
• Study Completion (Actual): February 18, 2021

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: November 2, 2018
• First Posted (Actual): November 5, 2018

Study Record Updates

• Last Update Posted (Actual): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Signs and Symptoms, Respiratory; Sarcoma; Hypoxia
• Other Study ID Numbers: 830018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No