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

NCT03730077 | Terminated Phase 1 FDA Drug

• 1 other identifier: 830018
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Sarcoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Marker of STS Hypoxia

  2 years

• Relationship of sarcoma hypoxia to glycolysis

  2 years

• Predictors of in vitro PLOD2 expression levels

  2 years

Study Arms (2)

18F-MISO PET/CT Test Retest

EXPERIMENTAL

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-MISO PET/CT

EXPERIMENTAL

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

Interventions

18F-FMISO DRUG

18F-FMISO PET/CT

18F-MISO PET/CT; 18F-MISO PET/CT Test Retest

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Sarcoma

Interventions

fluoromisonidazole

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 5, 2018
• Study Start: February 1, 2019
• Primary Completion: February 18, 2021
• Study Completion: February 18, 2021
• Last Updated: March 18, 2021

Record last verified: 2021-03

Locations

US (1)