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

Rectal Neoplasms Clinical Trial

Official title:

Pilot Study of Gene Expression and FDG-PET/MR Biomarkers for Evaluation of Response to Neoadjuvant Therapy for Locally Advanced Rectal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02112162
• Other study ID #: 201401064
• Status: Terminated
• Phase: Phase 1
• First received: April 9, 2014
• Last updated: December 7, 2016
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Rectal Neoplasms

Intervention

Radiation:
• fludeoxyglucose F 18
Undergo FDG PET/MRI

Device:
• positron emission tomography
Undergo FDG PET/MRI
• magnetic resonance imaging
Undergo FDG PET/MRI

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No

External Links

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