Back to resultsGene Expression and FDG PET/MRI in Evaluating Treatment Response in Patients With Locally Advanced Rectal Cancer Undergoing Chemotherapy and Radiation Therapy Before Surgery
Primary Purpose
Rectal Neoplasms
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
fludeoxyglucose F 18
positron emission tomography
magnetic resonance imaging
laboratory biomarker analysis
Sponsored by
About this trial
This is an interventional diagnostic trial for Rectal Neoplasms
Eligibility 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.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (FDG PET/MRI, gene expression)
Arm Description
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
Outcomes
Primary Outcome Measures
Change in FDG-PET/MR SUVmax
Images will be evaluated semi-quantitatively. Changes in imaging parameters will be correlated with pathologic response.
Change in FDG-PET/MR SUVmean
Images will be evaluated semi-quantitatively. Changes in imaging parameters will be correlated with pathologic response.
Change in ADCmean
Images will be evaluated semi-quantitatively. Changes in imaging parameters will be correlated with pathologic response.
Radiosensitivity index
Index is calculated based on tumor gene expression. Will be correlated with the descriptive changes in FDG-PET/MR SUV and ADC parameters.
Secondary Outcome Measures
Full Information
NCT ID
NCT02112162
First Posted
April 9, 2014
Last Updated
December 7, 2016
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02112162
Brief Title
Gene Expression and FDG PET/MRI in Evaluating Treatment Response in Patients With Locally Advanced Rectal Cancer Undergoing Chemotherapy and Radiation Therapy Before Surgery
Official Title
Pilot Study of Gene Expression and FDG-PET/MR Biomarkers for Evaluation of Response to Neoadjuvant Therapy for Locally Advanced Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
Loss of funding
Study Start Date
June 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Neoplasms
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (FDG PET/MRI, gene expression)
Arm Type
Experimental
Arm Description
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
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18
Other Intervention Name(s)
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
Intervention Description
Undergo FDG PET/MRI
Intervention Type
Device
Intervention Name(s)
positron emission tomography
Other Intervention Name(s)
FDG-PET, PET, PET scan, tomography, emission computed
Intervention Description
Undergo FDG PET/MRI
Intervention Type
Device
Intervention Name(s)
magnetic resonance imaging
Other Intervention Name(s)
MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Intervention Description
Undergo FDG PET/MRI
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Change in FDG-PET/MR SUVmax
Description
Images will be evaluated semi-quantitatively. Changes in imaging parameters will be correlated with pathologic response.
Time Frame
Baseline to up to 2 weeks before surgery
Title
Change in FDG-PET/MR SUVmean
Description
Images will be evaluated semi-quantitatively. Changes in imaging parameters will be correlated with pathologic response.
Time Frame
Baseline to up to 2 weeks before surgery
Title
Change in ADCmean
Description
Images will be evaluated semi-quantitatively. Changes in imaging parameters will be correlated with pathologic response.
Time Frame
Baseline to up to 2 weeks before surgery
Title
Radiosensitivity index
Description
Index is calculated based on tumor gene expression. Will be correlated with the descriptive changes in FDG-PET/MR SUV and ADC parameters.
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Parag Parikh, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
Gene Expression and FDG PET/MRI in Evaluating Treatment Response in Patients With Locally Advanced Rectal Cancer Undergoing Chemotherapy and Radiation Therapy Before Surgery
We'll reach out to this number within 24 hrs