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

NCT01525056 | Completed Phase 2

• 1 other identifier: LRCP01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Keywords

rectal cancer; imaging; PET; MRI

Outcome Measures

Primary Outcomes (1)

• efficacy of PET, CT-perfusion and MRI to stage patients with rectal cancer

  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

  3 years

Study Arms (1)

imaging with ct, mri and pet scans

OTHER

ct,mri and pet scans pre and post radiation

Radiation: ct and mri scans; Radiation: ct, mri and pet scan; Radiation: ct, mri and pet scans

Interventions

ct and mri scans RADIATION

ct and mri scan preradiation and postradiation

imaging with ct, mri and pet scans

ct, mri and pet scan RADIATION

ct, mri and pet scans preradiation and postradiation

imaging with ct, mri and pet scans

ct, mri and pet scans RADIATION

single arm with ct, mri and pet scans pre and post radiation

imaging with ct, mri and pet scans

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rectal cancer, stage T2, T3, T4

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre: lead

Study Sites (1)

London Regional Cancer Program

London, Ontario, N6A4L6, Canada

Location

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Barbara J Fisher, MD

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 25, 2012
• First Posted: February 2, 2012
• Study Start: March 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: September 9, 2014

Record last verified: 2014-09

Locations

CA (1)