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

NCT ID: NCT03730077

Last Updated: 2021-03-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2021-02-18

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

18F-FMISO

Intervention Type: DRUG

18F-FMISO PET/CT

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

Group Type: EXPERIMENTAL

18F-FMISO

Intervention Type: DRUG

18F-FMISO PET/CT

Interventions

18F-FMISO

18F-FMISO PET/CT

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

830018

Identifier Type: -

Identifier Source: org_study_id