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

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ClinicalTrials.gov Identifier: NCT01525056
Recruitment Status : Completed
First Posted : February 2, 2012
Last Update Posted : September 9, 2014
Sponsor:
Information provided by (Responsible Party):
Barbara Fisher, London Health Sciences Centre

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

  Show Detailed Description

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans
U.S. FDA Resources

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



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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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    Key Record Dates
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