This trial has been completed.

Condition rectal neoplasms
Treatments fludeoxyglucose f 18, positron emission tomography, magnetic resonance imaging, laboratory biomarker analysis
Phase phase 1
Sponsor Washington University School of Medicine
Start date June 2014
End date March 2015
Trial size 2 participants
Trial identifier NCT02112162, 201401064


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
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
fludeoxyglucose f 18 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
positron emission tomography FDG-PET, PET, PET scan, tomography, emission computed
magnetic resonance imaging MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
laboratory biomarker analysis
Correlative studies

Primary Outcomes

Change in FDG-PET/MR SUVmax
time frame: Baseline to up to 2 weeks before surgery
Change in FDG-PET/MR SUVmean
time frame: Baseline to up to 2 weeks before surgery
Change in ADCmean
time frame: Baseline to up to 2 weeks before surgery
Radiosensitivity index
time frame: Baseline

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Pilot Study of Gene Expression and FDG-PET/MR Biomarkers for Evaluation of Response to Neoadjuvant Therapy for Locally Advanced Rectal Cancer
Principal investigator Parag Parikh, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.
Location data was received from the National Cancer Institute and was last updated in December 2016.