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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
Sponsor:
Information provided by (Responsible Party):
W.B. Veldhuis, MD PhD, UMC Utrecht

Brief 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.


Condition or disease Intervention/treatment Phase
Cervical Cancer Other: 7T MRI Not Applicable

Detailed Description:
See brief summary

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arm Intervention/treatment
7T MRI
All subjects are entered into a single arm.
Other: 7T MRI
Ultra high field magnetic resonance imaging




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

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 ClinicalTrials.gov identifier (NCT number): NCT02083848


Locations
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Netherlands
UMC Utrecht
Utrecht, Netherlands, 3508 GA
Sponsors and Collaborators
UMC Utrecht
Investigators
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Study Director: Jacob P Hoogendam, MD UMC Utrecht
Principal Investigator: Wouter B Veldhuis, MD PhD UMC Utrecht
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Responsible Party: W.B. Veldhuis, MD PhD, Radiologist, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02083848    
Other Study ID Numbers: NL41056.041.13
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: November 2015
Keywords provided by W.B. Veldhuis, MD PhD, UMC Utrecht:
Locoregional invasion
Stage IB1, IB2, IIA or IIB
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases