PET/MR for Staging Rectal Cancer Patients With and Without EMVI-MR

June 19, 2020 updated by: Marcelo Araujo Queiroz, Instituto do Cancer do Estado de São Paulo

The Use of PET/MR for Initial Staging of Rectal Cancer Patients With Extramural Vascular Invasion Detected by MR (EMVI-MR)

The hypothesis to be proven with this study is that the use of PET/MR on the initial staging of rectal cancers in patients with extramural vascular invasion detected by MR will detect more lesions than conventional work-up and will significantly impact on therapeutic decision, improving disease free and overall survival.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • São Paulo, Brazil, 01255000
        • Instituto do Cancer do Estado de Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with histologically proven rectal cancer.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
EMVI-MR positive
Patients with primary rectal cancer and extramural vascular invasion detected by staging MR
EMVI-MR negative
Patients with primary rectal cancer and without extramural vascular invasion detected by staging MR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection rate
Time Frame: 12 months
Number of metastatic lesions detected
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Impact
Time Frame: 12 months
Measured by change in patient's therapy through questionnaire applied to referring physician
12 months
Progression-free survival
Time Frame: 36 months
Measured in terms of loco-regional or distant recurrence by 3 years.
36 months
Overall survival
Time Frame: 36 months
Measured in terms of death related to disease by 3 years.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Carlos Buchpiguel, MD, PhD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

August 30, 2015

First Submitted That Met QC Criteria

August 30, 2015

First Posted (Estimate)

September 1, 2015

Study Record Updates

Last Update Posted (Actual)

June 22, 2020

Last Update Submitted That Met QC Criteria

June 19, 2020

Last Verified

June 1, 2020

More Information

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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