Detection of Loco-regional Invasion of Cervical Cancer With 7 Tesla MRI (DETECT)
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|ClinicalTrials.gov Identifier: NCT02083848|
Recruitment Status : Completed
First Posted : March 11, 2014
Last Update Posted : November 3, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Other: 7T MRI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Detection of Loco-regional Invasion of Cervical Cancer With 7 Tesla MRI (DETECT)|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
All subjects are entered into a single arm.
Other: 7T MRI
Ultra high field magnetic resonance imaging
- Optimized T2w ultra high field (7T) MRI sequence of the (para)cervical area which allow qualitative assessment of the loco-regional invasion of cervical cancer. [ Time Frame: Up to 2 years from study initiation ]
This is a feasibility outcome (feasibility study). This pilot study does not aim to test diagnostic accuracy. The (feasibility) criteria when this 7T MRI protocol is deemed optimized are:
- Successful depiction, at minimum, of the anatomy present in the inner pelvis (at the cervical level) in three orthogonal planes;
- Sufficient T2w contrast in the created datasets for clinical diagnostic applicability. This includes sufficient T2w contrast within the cervix to be able to delineate its subanatomy (e.g. mucosa vs. fibrous tissue);
- Absence of image distorting artefacts, which reduce the clinical diagnostic applicability, regardless of their cause;
- The overall protocol does not exceed 45 minutes of scan time;
- Reproducibility of the above mentioned criteria.
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 ClinicalTrials.gov identifier (NCT number): NCT02083848
|Utrecht, Netherlands, 3508 GA|
|Study Director:||Jacob P Hoogendam, MD||UMC Utrecht|
|Principal Investigator:||Wouter B Veldhuis, MD PhD||UMC Utrecht|