- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02537340
PET/MR for Staging Rectal Cancer Patients With and Without EMVI-MR
The Use of PET/MR for Initial Staging of Rectal Cancer Patients With Extramural Vascular Invasion Detected by MR (EMVI-MR)
Study Overview
Status
Conditions
Detailed Description
The accurate staging of rectal cancer is essential to define therapy and for prognosis assessment. Imaging modalities usually provide useful information for pre-operative planning of primary tumour resection and may indicate the need of neoadjuvant treatment. It is recommended the use of magnetic resonance imaging (MRI) for local staging and computed tomography (CT) of chest, abdomen and pelvis for detection of distant metastasis. Patients with rectal cancer and vascular invasion might benefit from an intensive pre-operative staging in order to early detect distant metastasis, favouring a better therapeutic planning. There is no consensus regarding the use of PET/MR for initial staging of patients with rectal cancer. It has been shown that although changing pattern's in patients' stage, the use of PET/MR for colorectal cancers did not impact disease management. New studies are required for identifying the subgroup of patients with changes in the pre-operative MR that might benefit from the use of PET/MR for initial staging of rectal cancers.
Patients with rectal cancer will undergo pelvic MR, whole-body CT and whole-body PET/MR. According to the tumour characteristics on MR, there will be defined two group of patients: with EMVI-RM (group A) and without EMVI-MR (group B). The whole-body CT and PET/MR will be evaluated for the detection of loco-regional lymph nodes disease and distant metastasis. The total number of lesions and their respective sites will be recorded and compared for each method. The PET/MR management impact will be determined from the medical record or by direct contact with the treating clinician. The impact of PET/MR on management will be defined as high (the treatment modality or intent was changed), medium (the treatment modality or intent remained unchanged, although the method of treatment delivery or planned diagnostic procedure was changed), low (PET/MR results were consistent with planned management, and treatment modality or intent was unchanged), or none (the management plan was not changed, despite being inconsistent with the PET/MR stage-that is, PET/MR results were ignored). Overall survival will be used to evaluate prognostic significance. Clinical follow-up will be performed 3 monthly for 2 years. Imaging and, eventually biopsy, will be performed to evaluate symptoms or signs suggestive of residual or recurrent disease.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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São Paulo, Brazil, 01255000
- Instituto do Cancer do Estado de Sao Paulo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 18 years;
- No contraindication to MRI (eletromagnetic devices, claustrophobia);
- No contraindication to PET/MR (hyperglycemia, claustrophobia);
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Local resection of rectal tumor;
- Non-colorectal synchronic lesion;
- Previous treatment (chemo or radiation therapy) for rectal cancer;
- Renal insufficiency;
- Pregnancy, lactation or inadequate contraception
- Known allergy to contrast media (CT, MR or PET);
- Blood glucose level higher than 150 mg/dl.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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EMVI-MR positive
Patients with primary rectal cancer and extramural vascular invasion detected by staging MR
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EMVI-MR negative
Patients with primary rectal cancer and without extramural vascular invasion detected by staging MR
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detection rate
Time Frame: 12 months
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Number of metastatic lesions detected
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Impact
Time Frame: 12 months
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Measured by change in patient's therapy through questionnaire applied to referring physician
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12 months
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Progression-free survival
Time Frame: 36 months
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Measured in terms of loco-regional or distant recurrence by 3 years.
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36 months
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Overall survival
Time Frame: 36 months
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Measured in terms of death related to disease by 3 years.
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36 months
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Carlos Buchpiguel, MD, PhD, University of Sao Paulo
Publications and helpful links
General Publications
- Queiroz MA, Ortega CD, Ferreira FR, Capareli FC, Nahas SC, Cerri GG, Buchpiguel CA. Value of Primary Rectal Tumor PET/MRI in the Prediction of Synchronic Metastatic Disease. Mol Imaging Biol. 2022 Jun;24(3):453-463. doi: 10.1007/s11307-021-01674-1. Epub 2021 Nov 9. Erratum In: Mol Imaging Biol. 2022 Jan 4;:
- Queiroz MA, Ortega CD, Ferreira FR, Nahas SC, Cerri GG, Buchpiguel CA. Diagnostic accuracy of FDG-PET/MRI versus pelvic MRI and thoracic and abdominal CT for detecting synchronous distant metastases in rectal cancer patients. Eur J Nucl Med Mol Imaging. 2021 Jan;48(1):186-195. doi: 10.1007/s00259-020-04911-x. Epub 2020 Jun 20.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NP796/15
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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