Cervical Cancer Clinical Trial
Official title:
Detection of Loco-regional Invasion of Cervical Cancer With 7 Tesla MRI (DETECT)
Background of the study: The accurate assessment of local cervical cancer spread (i.e.
invasion) is of clinical importance for staging and treatment considerations. For example,
if parametrial invasion is absent, radical surgery is the treatment of choice for tumors
less than 4cm in diameter. However, if such invasion is present, the patient has become
inoperable and (chemo)radiotherapy is warranted. Unfortunately, regular 1.5T MRI as a part
of staging work-up has a limited accuracy for detecting loco-regional tumor invasion. Due to
relatively frequent false-negative findings a risk of understaging and under-treatment
occurs. For such cases adjuvant treatments with (chemo)radiotherapy are indicated after the
initial surgery, causing increased morbidity and treatment associated risks. For higher
stages, with primary (chemo)radiotherapy, a more reliable MRI based delineation of local
tumor spread could enable individualized dose(volume) and field modifications.
Hypothesis/aim of the study: To develop and in vivo optimize T2w ultra high field (7T) MRI
sequences, which use a combination of an endorectal and external coil, to image the
(para)cervical area for assessment of the loco-regional tumor status in cervical cancer.
Study design: The proposed study is an investigator initiated, single center, prospective
pilotstudy.
Study population: 20 patients with histological proven cervical cancer stage IB1, IB2, IIA
of IIB will be included.
Primary study parameters/outcome of the study: Optimized T2w ultra high field (7T) MRI
sequences of the (para)cervical area which allow qualitative assessment of the loco-regional
invasion of cervical cancer.
See brief summary ;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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