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

December 7, 2016 updated by: Washington University School of Medicine

Pilot Study of Gene Expression and FDG-PET/MR Biomarkers for Evaluation of Response to Neoadjuvant Therapy for Locally Advanced Rectal Cancer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Biopsy-proven adenocarcinoma of the rectum.
  • Surgical candidate.
  • Candidate for neoadjuvant chemotherapy.
  • Clinical evidence of T1-3N1 or T3N0 disease. This can be either by imaging studies or by physical exam findings.
  • At least 18 years of age.
  • Zubrod performance status of 0-2.
  • Able to understand and willing to sign a written informed consent document.
  • Patients with distant metastatic disease will be eligible if they satisfy all other conditions.

Exclusion Criteria:

  • Pregnant.
  • Past history of pelvic radiotherapy.
  • Received prior chemotherapy for colorectal cancer.
  • Uncontrolled diabetes with a fasting glucose ≥ 200 mg/dl at the time of PET/MRI imaging.
  • Claustrophobia or any other contraindication to MRI imaging evaluated by a standardized safety questionnaire.
  • Renal insufficiency (defined as glomerular filtration rate (GFR < 30 mL/min/1.73 m2) measured no more than 60 days before the first research scan) which precludes safe administration of the contrast agent.
  • Currently on dialysis.
  • Known prior allergic reaction to gadolinium-based MR contrast agents.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (FDG PET/MRI, gene expression)
FDG PET/MRI at baseline and at 2-4 weeks before surgery (after neoadjuvant chemoradiation). Tissue samples for gene expression at baseline and during surgery
Other: laboratory biomarker analysis
Correlative studies
Radiation: fludeoxyglucose F 18
Undergo FDG PET/MRI
Other Names:
  • 18 FDG, 18FDG, 2-F18-fluoro-2-deoxy-D-glucose, 2-F18-fluoro-2-deoxyglucose, 63503-12-8, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18
Device: positron emission tomography
Undergo FDG PET/MRI
Other Names:
  • FDG-PET, PET, PET scan, tomography, emission computed
Device: magnetic resonance imaging
Undergo FDG PET/MRI
Other Names:
  • MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in FDG-PET/MR SUVmax
Time Frame: Baseline to up to 2 weeks before surgery
Images will be evaluated semi-quantitatively. Changes in imaging parameters will be correlated with pathologic response.
Baseline to up to 2 weeks before surgery
Change in FDG-PET/MR SUVmean
Time Frame: Baseline to up to 2 weeks before surgery
Images will be evaluated semi-quantitatively. Changes in imaging parameters will be correlated with pathologic response.
Baseline to up to 2 weeks before surgery
Change in ADCmean
Time Frame: Baseline to up to 2 weeks before surgery
Images will be evaluated semi-quantitatively. Changes in imaging parameters will be correlated with pathologic response.
Baseline to up to 2 weeks before surgery
Radiosensitivity index
Time Frame: Baseline
Index is calculated based on tumor gene expression. Will be correlated with the descriptive changes in FDG-PET/MR SUV and ADC parameters.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

April 9, 2014

First Submitted That Met QC Criteria

April 10, 2014

First Posted (Estimate)

April 11, 2014

Study Record Updates

Last Update Posted (Estimate)

December 8, 2016

Last Update Submitted That Met QC Criteria

December 7, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201401064

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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