NCT02083848

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 3, 2015

Status Verified

November 1, 2015

Enrollment Period

1.7 years

First QC Date

March 4, 2014

Last Update Submit

November 2, 2015

Conditions

Cervical Cancer

Keywords

Locoregional invasionStage IB1, IB2, IIA or IIB

Outcome Measures

Primary Outcomes (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.

    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

Study Arms (1)

7T MRI

OTHER

All subjects are entered into a single arm.

Other: 7T MRI

Interventions

7T MRIOTHER

Ultra high field magnetic resonance imaging

7T MRI

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven primary malignancy of the cervix uteri;
  • FIGO stage IB1, IB2, IIA or IIB;
  • ≥18 years;
  • Written inform consent provided.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Utrecht

Utrecht, Utrecht, 3508 GA, Netherlands

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Jacob P Hoogendam, MD

    UMC Utrecht

    STUDY DIRECTOR

  • Wouter B Veldhuis, MD PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Radiologist

Study Record Dates

First Submitted

March 4, 2014

First Posted

March 11, 2014

Study Start

March 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 3, 2015

Record last verified: 2015-11

Locations

NL(1)