Detection of Loco-regional Invasion of Cervical Cancer With 7 Tesla MRI (DETECT)

November 2, 2015 updated by: W.B. Veldhuis, MD PhD, UMC Utrecht

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

See brief summary

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3508 GA
        • UMC Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 2 years from study initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Investigators

  • Study Director: Jacob P Hoogendam, MD, UMC Utrecht
  • Principal Investigator: Wouter B Veldhuis, MD PhD, UMC Utrecht

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

March 4, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (Estimate)

March 11, 2014

Study Record Updates

Last Update Posted (Estimate)

November 3, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL41056.041.13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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