Rectal Neoplasms
Conditions
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.
Interventions
RADIATIONfludeoxyglucose F 18
Undergo FDG PET/MRI
DEVICEpositron emission tomography
Undergo FDG PET/MRI
DEVICEmagnetic resonance imaging
Undergo FDG PET/MRI
OTHERlaboratory biomarker analysis
Correlative studies
Sponsors
Washington University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in FDG-PET/MR SUVmax | 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 | 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 | 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 | Baseline | Index is calculated based on tumor gene expression. Will be correlated with the descriptive changes in FDG-PET/MR SUV and ADC parameters. |
Countries
United States
Outcome results
None listed