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

NCT02112162 | Terminated Phase 1

• 1 other identifier: 201401064
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Neoplasms

Outcome Measures

Primary Outcomes (4)

• Change in FDG-PET/MR SUVmax

  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

  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

  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

  Index is calculated based on tumor gene expression. Will be correlated with the descriptive changes in FDG-PET/MR SUV and ADC parameters.

  Baseline

Study Arms (1)

Diagnostic (FDG PET/MRI, gene expression)

EXPERIMENTAL

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; Device: positron emission tomography; Device: magnetic resonance imaging; Other: laboratory biomarker analysis

Interventions

fludeoxyglucose F 18 RADIATION

Undergo FDG PET/MRI

Also known as: 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

Diagnostic (FDG PET/MRI, gene expression)

positron emission tomography DEVICE

Undergo FDG PET/MRI

Also known as: FDG-PET, PET, PET scan, tomography, emission computed

Diagnostic (FDG PET/MRI, gene expression)

magnetic resonance imaging DEVICE

Undergo FDG PET/MRI

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

Diagnostic (FDG PET/MRI, gene expression)

laboratory biomarker analysis OTHER

Correlative studies

Diagnostic (FDG PET/MRI, gene expression)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Fluorodeoxyglucose F18; Positron-Emission Tomography; Tomography; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Diagnostic Techniques, Radioisotope

Study Officials

• Parag Parikh, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 11, 2014
• Study Start: June 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: December 1, 2016
• Last Updated: December 8, 2016

Record last verified: 2016-12

Locations

US (1)