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NCT02317302 · ClinicalTrials.gov registry record · Phase 1

FDG Tumor Heterogeneity During Chemoradiation as a Predictor of Response in Patients With Cervical Cancer

A Phase 1 study, sponsored by Washington University School of Medicine.

Terminated
Registry status
Phase 1
Development phase
48
Enrollment target

NCT02317302: Clinical Trial Phase 1 study, sponsored by Washington University School of Medicine.

NCT02317302 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02317302, a Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.

TERMINATED
Registry status
Phase 1
Development phase
48 participants
Enrollment target

Study Summary

In this study, 50 evaluable patients will undergo one FDG-PET study during their chemoradiation, in addition to the standard of care pretreatment and 3-month post-treatment clinical FDG-PET/CT or FDG-PET/MR scans. From all FDG-PET studies, tumor volume, SUVmax, FDGhetero, and texture maps will be obtained. Evaluating the changes in tumor SUVmax and heterogeneity during treatment will aid in better understanding the role of these biological parameters in inadequate response to chemoradiation. Other researchers, using MRI imaging, have evaluated changes in the cervical tumor volume during treatment. The investigators expect there will be variation in how cervical tumors shrink and change during chemoradiation and therefore we are going to use multiple measures in addition to tumor volume to evaluate cervical tumor metabolic heterogeneity. Being able to predict at diagnosis the patients who are at higher risk for persistent disease following chemoradiation would allow for future studies where these high risk patients could be specifically targeted with more aggressive therapy.

Primary Outcome

Using texture analysis

Interventions

  • DEVICE FDG-PET/MR
  • DEVICE FDG-PET/CT

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2011-06-28
Est. Completion 2020-06-02
Phase Phase 1

Why NCT02317302 stopped before completion

NCT02317302 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).

The record links to 0 conditions, and to 2 interventions - of which FDG-PET/MR is the first listed.

NCT02317302 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02317302 about?

NCT02317302 is a clinical study titled "FDG Tumor Heterogeneity During Chemoradiation as a Predictor of Response in Patients With Cervical Cancer". In this study, 50 evaluable patients will undergo one FDG-PET study during their chemoradiation, in addition to the standard of care pretreatment and 3-month post-treatment clinical FDG-PET/CT or FDG-PET/MR scans. From all FDG-PET studies, tumor volume, SUVmax, FDGhetero, and texture maps will be ob...

What is the current status of trial NCT02317302?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2011-06-28. Estimated completion is 2020-06-02.

What interventions are being tested in trial NCT02317302?

The interventions under investigation include: FDG-PET/MR (DEVICE), FDG-PET/CT (DEVICE).

Who is sponsoring clinical trial NCT02317302?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02317302's enrollment target sits among peer trials

48 1025th of 2000 higher than 948 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 NCT02317302, the US trial registry maintained by the National Library of Medicine. NCT02317302 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.