Detection of Loco-regional Invasion of Cervical Cancer With 7 Tesla MRI
Conditions
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
Locoregional invasion, Stage IB1, IB2, IIA or IIB
Study Type
Interventional
Study Phase
N/A
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: 7T MRI
Type: Other
Overall Status
Recruiting
Summary
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.
Detailed Description
See brief summary
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Histologically proven primary malignancy of the cervix uteri;

- FIGO stage IB1, IB2, IIA or IIB;

- ≥18 years;

- Written inform consent provided.

Exclusion Criteria:

- Contra-indications for MRI: Any non-removable electronic or ferromagnetic object present in the body; Pregnancy; Severe claustrophobia; Unable to lie still and completely horizontal for minimally 45 minutes;

- Body weight >150kg;

- Any type of neo-adjuvant chemo- and/or radiotherapy for cervical cancer;

- Uterine prolapse with C ≥ -6 cm (POP-Q).
Location
UMC Utrecht
Utrecht, Netherlands
Status: Recruiting
Contact: Jacob P Hoogendam, MD - +31887553701 - j.hoogendam@umuctrecht.nl
Start Date
March 2014
Completion Date
January 2016
Sponsors
UMC Utrecht
Source
UMC Utrecht
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page