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

Soft Tissue Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03730077
• Other study ID #: 830018
• Status: Terminated
• Phase: Phase 1
• Start date: February 1, 2019
• Est. completion date: February 18, 2021

Study information

• Verified date: March 2021
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: February 18, 2021
• Est. primary completion date: February 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypoxia
• Sarcoma
• Soft Tissue Sarcoma

Intervention

Drug:
• 18F-FMISO
18F-FMISO PET/CT

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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-1a, and CAIX) obtained from immunohistochemistry	2 years
Secondary	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
Secondary	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-1a and CAIX, and other hypoxia markers.	2 years