Rectal Cancer: Local Staging, Re-staging and Assessment of Lymph Nodes Using Pet-Ct, CT-Perfusion and 3T MRI

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this study is to evaluate the accuracy of Positron emission tomography, Computed Tomography perfusion and 3 Tesla MRI in the radiological down-staging of rectal cancer following neoadjuvant chemoradiation. The restaging result obtained by these imaging studies will be compared to standard imaging studies and the histopathology of the surgical specimen. We hypothesize that these 3 imaging modalities will detect lymph node metastases pretreatment better than standard pretreatment scans and will better determine the degree of response of the primary rectal tumor to preoperative chemoradiation.

Condition or disease	Intervention/treatment	Phase
Rectal Cancer	Radiation: ct and mri scans; Radiation: ct, mri and pet scan; Radiation: ct, mri and pet scans	Phase 2

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	30 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
Official Title:	Rectal Cancer: Local Staging, Re-staging and Assessment of Lymph Node Metastases Using PET-CT, CT-Perfusion and 3T MRI: A Prospective Feasibility Study
Study Start Date :	March 2012
Actual Primary Completion Date :	September 2014
Actual Study Completion Date :	September 2014

Arms and Interventions

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Arm	Intervention/treatment
imaging with ct, mri and pet scans; ct,mri and pet scans pre and post radiation	Radiation: ct and mri scans; ct and mri scan preradiation and postradiation Radiation: ct, mri and pet scan; ct, mri and pet scans preradiation and postradiation Radiation: ct, mri and pet scans; single arm with ct, mri and pet scans pre and post radiation

Outcome Measures

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Primary Outcome Measures :

1. efficacy of PET, CT-perfusion and MRI to stage patients with rectal cancer [ Time Frame: 3 years ]
   The patient will undergo imaging studies with PET, CT-perfusion and MRI before and after standard preoperative chemoradiation and these imaging studies will be compared with standard imaging and with the final pathology specimen in order to determine the accuracy of these 3 studies in detecting lymph node metastases and response of the primary tumour to treatment

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Rectal cancer, stage T2, T3, T4

Exclusion Criteria:

• Rectal cancer, stage T1 or metastatic
• Non-rectal primary cancer invading the rectum
• Mucinous histology
• Patient is initially, or becomes a non-surgical candidate during the course of the study
• Hip prosthesis (affects PET-CT image processing)
• Allergy to CT contrast or patients with impaired renal function, defined as estimated glomerular filtrate rate (eGFR)< 30 ml/min
• Prior radiotherapy to the region of the study that would result in overlap of radiation fields
• Contraindications to MRI
• Pregnancy

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Canada, Ontario
London Regional Cancer Program
London, Ontario, Canada, N6A4L6

Sponsors and Collaborators

London Health Sciences Centre

Investigators

Principal Investigator:	Barbara J Fisher, MD	University of Western Ontario, Canada

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Barbara Fisher, Doctor, London Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT01525056 History of Changes
Other Study ID Numbers:	LRCP01
First Posted:	February 2, 2012
Last Update Posted:	September 9, 2014
Last Verified:	September 2014

Keywords provided by Barbara Fisher, London Health Sciences Centre:

rectal cancer; imaging; PET; MRI

Additional relevant MeSH terms:

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