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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2012 by London Health Sciences Centre
Sponsor:
Information provided by (Responsible Party):
Barbara Fisher, London Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01525056
First received: January 25, 2012
Last updated: January 31, 2012
Last verified: January 2012
  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
Device: MRI,PET-CT and CT-Perfusion studies
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:


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


Estimated Enrollment: 30
Study Start Date: February 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Imaging
Imaging studies with PET-CT,CT-perfusion,MRI pelvis pre- and post- standard chemoradiation and comparison with pathology specimen
Device: MRI,PET-CT and CT-Perfusion studies

3 Tesla MRI Unit(Device Siemens Medical, Germany ):

  • Buscopan 40 mg IM/3-T IV
  • Axial T2 TSE of pelvis
  • Sagittal T2 TSE
  • Axial oblique T2 TSE
  • Coronal T2 TSE
  • Axial DWI
  • ADC map

PET-CT (Device):

  • Intravenous injection of 5MBq/kg of F-18 FDG
  • Intravenous injection of 20 mg Lasix
  • IV hydration with 250-500 mL of saline
  • 60 minutes post-injection, acquire non contrast CT and PET imaging

CT Perfusion (Device):64-slice CT scanner (Discovery CT750 HD, GE Healthcare, )

  • Preliminary non-contrast 2.5-mm-thick helical CT of the pelvis
  • Contrast injected at a rate of 3-4 ml/s at a dose is 0.8ml/kg of body weight up to 70 ml of contrast at a concentration of 370 mg iodine/ml.
  • Acquire dynamic contrast enhanced (DCE) images will be analyzed by CT Perfusion to determine blood flow, blood volume, mean transit time and capillary permeability surface area of the tumor.

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  Eligibility

Ages Eligible for Study:   18 Years and older
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

Contacts
Contact: Barbara J Fisher, MD 519-685-8650 barbara.fisher@lhsc.on.ca
Contact: Kassam Zahra, MD 519-686-6000 zkassam@sjhc.on.ca

Locations
Canada, Ontario
London Regional Cancer Program Not yet recruiting
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

No publications provided

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: January 31, 2012
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 July 29, 2014