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

NCT ID: NCT02083848

Last Updated: 2015-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2015-11-30

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.

Detailed Description

See brief summary

Conditions

Cervical Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

7T MRI

All subjects are entered into a single arm.

Group Type: OTHER

7T MRI

Intervention Type: OTHER

Ultra high field magnetic resonance imaging

Interventions

7T MRI

Ultra high field magnetic resonance imaging

Intervention Type: OTHER

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

UMC Utrecht

OTHER

Sponsor Role: lead

Responsible Party

W.B. Veldhuis, MD PhD

Radiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacob P Hoogendam, MD

Role: STUDY_DIRECTOR

UMC Utrecht

Wouter B Veldhuis, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

UMC Utrecht

Utrecht, Utrecht, Netherlands

Countries

Netherlands

Other Identifiers

NL41056.041.13

Identifier Type: -

Identifier Source: org_study_id