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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Barbara Fisher, London Health Sciences Centre

ClinicalTrials.gov Identifier:

NCT01525056

First received: January 25, 2012

Last updated: September 8, 2014

Last verified: September 2014

History of Changes

Purpose

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	Intervention	Phase
Rectal Cancer	Radiation: ct and mri scans Radiation: ct, mri and pet scan Radiation: ct, mri and pet scans	Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Nuclear Scans

Genetic and Rare Diseases Information Center resources: Rectal Neoplasm

U.S. FDA Resources

Further study details as provided by London Health Sciences Centre:

Primary Outcome Measures:

efficacy of PET, CT-perfusion and MRI to stage patients with rectal cancer [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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


Enrollment:	30
Study Start Date:	March 2012
Study Completion Date:	September 2014
Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01525056

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


Responsible Party:	Barbara Fisher, Doctor, London Health Sciences Centre
ClinicalTrials.gov Identifier:	NCT01525056 History of Changes
Other Study ID Numbers:	LRCP01
Study First Received:	January 25, 2012
Last Updated:	September 8, 2014
Health Authority:	Canada: Health Canada

Keywords provided by 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

ClinicalTrials.gov processed this record on September 23, 2016

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