Rectal Neoplasms Clinical Trial
Official title:
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.
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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