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 |
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Recruitment Status :
Completed
First Posted : February 2, 2012
Last Update Posted : September 9, 2014
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Sponsor:
London Health Sciences Centre
Information provided by (Responsible Party):
Barbara Fisher, London Health Sciences Centre
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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
| Arm | Intervention/treatment |
|---|---|
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imaging with ct, mri and pet scans
ct,mri and pet scans pre and post radiation
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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 :
- 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, Older Adult) |
| 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:
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rectal cancer imaging PET MRI |
Additional relevant MeSH terms:
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Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |