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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02537340
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : June 22, 2020
GE Healthcare
Information provided by (Responsible Party):
Marcelo Araujo Queiroz, Instituto do Cancer do Estado de São Paulo

Brief Summary:
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.

Condition or disease
Rectal Neoplasms

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.

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Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Use of PET/MR for Initial Staging of Rectal Cancer Patients With Extramural Vascular Invasion Detected by MR (EMVI-MR)
Actual Study Start Date : September 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : May 2019

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

Primary Outcome Measures :
  1. Detection rate [ Time Frame: 12 months ]
    Number of metastatic lesions detected

Secondary Outcome Measures :
  1. Clinical Impact [ Time Frame: 12 months ]
    Measured by change in patient's therapy through questionnaire applied to referring physician

  2. Progression-free survival [ Time Frame: 36 months ]
    Measured in terms of loco-regional or distant recurrence by 3 years.

  3. Overall survival [ Time Frame: 36 months ]
    Measured in terms of death related to disease by 3 years.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with histologically proven rectal cancer.

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.

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 identifier (NCT number): NCT02537340

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Instituto do Câncer do Estado de São Paulo
São Paulo, Brazil, 01255000
Sponsors and Collaborators
Instituto do Cancer do Estado de São Paulo
GE Healthcare
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Study Director: Carlos Buchpiguel, MD, PhD University of São Paulo
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Marcelo Araujo Queiroz, MD, Instituto do Cancer do Estado de São Paulo Identifier: NCT02537340    
Other Study ID Numbers: NP796/15
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020
Keywords provided by Marcelo Araujo Queiroz, Instituto do Cancer do Estado de São Paulo:
Rectal cancer
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases