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

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03730077
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arms: 2
• Actual Duration (Months): 24.6
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Soft Tissue Sarcoma	Drug: 18F-FMISO	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 5 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Integrated Biomarker PET/CT Imaging Trial for Assessing Hypoxia in Soft Tissue Sarcomas Using a Novel PET/CT Tracer
• Actual Study Start Date: Feb 1, 2019
• Actual Primary Completion Date: Feb 18, 2021
• Actual Study Completion Date: Feb 18, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Hypoxia in FMISO PET/CT [2 years]

   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

1. Marker of STS Hypoxia [2 years]

   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. Relationship of sarcoma hypoxia to glycolysis [2 years]

   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

3. Predictors of in vitro PLOD2 expression levels [2 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104

Sponsors and Collaborators

• University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT03730077
• Other Study ID Numbers: 830018
• First Posted: Nov 5, 2018
• Last Update Posted: Mar 18, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sarcoma; Hypoxia

Study Results

No Results Posted as of Mar 18, 2021