Ignite Creation Date:
2024-05-06 @ 2:36 AM
Last Modification Date:
2024-10-26 @ 11:21 AM
Study NCT ID:
NCT02083848
Status:
COMPLETED
Last Update Posted:
2015-11-03
First Post:
2014-03-04
Brief Title:
Detection of Loco-regional Invasion of Cervical Cancer With 7 Tesla MRI
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Detection of Loco-regional Invasion of Cervical Cancer With 7 Tesla MRI DETECT
Status:
COMPLETED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DETECT
Brief Summary:
Background of the study The accurate assessment of local cervical cancer spread ie 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 chemoradiotherapy is warranted Unfortunately regular 15T 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 chemoradiotherapy are indicated after the initial surgery causing increased morbidity and treatment associated risks For higher stages with primary chemoradiotherapy a more reliable MRI based delineation of local tumor spread could enable individualized dosevolume and field modifications
Hypothesisaim 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 paracervical 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 parametersoutcome of the study Optimized T2w ultra high field 7T MRI sequences of the paracervical area which allow qualitative assessment of the loco-regional invasion of cervical cancer
Hypothesisaim 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 paracervical 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 parametersoutcome of the study Optimized T2w ultra high field 7T MRI sequences of the paracervical area which allow qualitative assessment of the loco-regional invasion of cervical cancer
Detailed Description:
See brief summary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None