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NCT02112162 · ClinicalTrials.gov registry record · Phase 1

Gene Expression and FDG PET/MRI in Evaluating Treatment Response in Patients With Locally Advanced Rectal Cancer Undergoing Chemotherapy and Radiation Therapy Before Surgery

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

Terminated
Registry status
Phase 1
Development phase
2
Enrollment target

NCT02112162: Clinical Trial Phase 1 study, sponsored by Washington University School of Medicine.

NCT02112162 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02112162, a Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.

TERMINATED
Registry status
Phase 1
Development phase
2 participants
Enrollment target

Study Summary

This pilot clinical trial studies gene expression analysis and fludeoxyglucose F 18 (FDG) positron emission tomography (PET)/magnetic resonance imaging (MRI) in evaluating treatment response in patients with rectal cancer that has spread to nearby tissue or lymph nodes undergoing chemotherapy and radiation therapy before surgery. Studying samples of tissue in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and may also help doctors predict a patient's response to treatment before surgery. PET-MRI is a procedure that combines the pictures from a PET scan and an MRI scan. The combined scans give more detailed pictures of areas inside the body than either scan gives by itself. PET-MRI may help determine how well people respond to pre-surgery chemotherapy and radiation therapy and help the surgeon make the best plan for removal of the tumor.

Primary Outcome

Images will be evaluated semi-quantitatively. Changes in imaging parameters will be correlated with pathologic response.

Interventions

  • OTHER laboratory biomarker analysis
  • RADIATION fludeoxyglucose F 18
  • DEVICE positron emission tomography
  • DEVICE magnetic resonance imaging

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2014-06
Est. Completion 2016-12
Phase Phase 1

Why NCT02112162 stopped before completion

NCT02112162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.

NCT02112162 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02112162 about?

NCT02112162 is a clinical study titled "Gene Expression and FDG PET/MRI in Evaluating Treatment Response in Patients With Locally Advanced Rectal Cancer Undergoing Chemotherapy and Radiation Therapy Before Surgery". This pilot clinical trial studies gene expression analysis and fludeoxyglucose F 18 (FDG) positron emission tomography (PET)/magnetic resonance imaging (MRI) in evaluating treatment response in patients with rectal cancer that has spread to nearby tissue or lymph nodes undergoing chemotherapy and ra...

What is the current status of trial NCT02112162?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2014-06. Estimated completion is 2016-12.

What interventions are being tested in trial NCT02112162?

The interventions under investigation include: laboratory biomarker analysis (OTHER), fludeoxyglucose F 18 (RADIATION), positron emission tomography (DEVICE), magnetic resonance imaging (DEVICE).

Who is sponsoring clinical trial NCT02112162?

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 NCT02112162's enrollment target sits among peer trials

2 2000th of 2000 the lowest 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 NCT02112162, the US trial registry maintained by the National Library of Medicine. NCT02112162 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.