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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 study has been terminated.
(Loss of funding)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02112162
First Posted: April 11, 2014
Last Update Posted: December 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
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.

Condition Intervention Phase
Rectal Neoplasms Radiation: fludeoxyglucose F 18 Device: positron emission tomography Device: magnetic resonance imaging Other: laboratory biomarker analysis Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study of Gene Expression and FDG-PET/MR Biomarkers for Evaluation of Response to Neoadjuvant Therapy for Locally Advanced Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 2
Study Start Date: June 2014
Study Completion Date: December 2016
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Radiation: fludeoxyglucose F 18
Undergo FDG PET/MRI
Other Name: 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 Name: FDG-PET, PET, PET scan, tomography, emission computed
Device: magnetic resonance imaging
Undergo FDG PET/MRI
Other Name: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Other: laboratory biomarker analysis
Correlative studies

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112162


Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Parag Parikh, M.D. Washington University School of Medicine
  More Information

Additional Information:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02112162     History of Changes
Other Study ID Numbers: 201401064
First Submitted: April 9, 2014
First Posted: April 11, 2014
Last Update Posted: December 8, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Fluorodeoxyglucose F18
Deoxyglucose
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antiviral Agents
Anti-Infective Agents