NCT03730077

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
DRUG	18F-FMISO	18F-FMISO PET/CT

Timeline

• Start date: 2019-02-01
• Primary completion: 2021-02-18
• Completion: 2021-02-18
• First posted: 2018-11-05
• Last updated: 2021-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study