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NCT03730077 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by University of Pennsylvania.

Terminated
Registry status
Phase 1
Development phase
5
Enrollment target

NCT03730077: Clinical Trial Phase 1 study, sponsored by University of Pennsylvania.

NCT03730077 is a Phase 1 study that was terminated before completion, run by University of Pennsylvania. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03730077, a Phase 1 study, was terminated before completion, sponsored by University of Pennsylvania.

TERMINATED
Registry status
Phase 1
Development phase
5 participants
Enrollment target

Study 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.

Primary Outcome

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

Interventions

  • DRUG 18F-FMISO

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2019-02-01
Est. Completion 2021-02-18
Phase Phase 1
University of Pennsylvania

1,423 total trials

Why NCT03730077 stopped before completion

NCT03730077 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 1 intervention - of which 18F-FMISO is the first listed.

NCT03730077 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03730077 about?

NCT03730077 is a clinical study titled "FMISO PET/CT Imaging Trial for Assessing Hypoxia in Soft Tissue Sarcomas". 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 Sys...

What is the current status of trial NCT03730077?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2019-02-01. Estimated completion is 2021-02-18.

What interventions are being tested in trial NCT03730077?

The interventions under investigation include: 18F-FMISO (DRUG).

Who is sponsoring clinical trial NCT03730077?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03730077's enrollment target sits among peer trials

5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03730077, the US trial registry maintained by the National Library of Medicine. NCT03730077 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.