NCT02160483

Brief Summary

Functional magnetic resonance imaging in women with chronic pelvic pain using arterial spin labelling, functional connectivity, diffusion tensor imaging and magnetic resonance spectroscopy.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

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

First Submitted

Initial submission to the registry

May 25, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 10, 2014

Completed
12 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

1 year

First QC Date

May 25, 2014

Last Update Submit

August 18, 2017

Conditions

Pelvis Pain ChronicEndometriosis of Uterus

Keywords

Chronic pelvic painEndometriosis

Outcome Measures

Primary Outcomes (1)

  • Number of participants with increase in insula anterior cingulate cortex signal on magnetic resonance imaging

    Magnetic resonance imaging using arterial spin labelling, functional connectivity, diffusion tensor imaging, magnetic resonance imaging

    1 hour

Secondary Outcomes (1)

  • Number of subjects in psychological testing with increased anxiety, depression and pain catastrophizing scores

    1 hour

Study Arms (1)

Magnetic resonance imaging

EXPERIMENTAL

Functional magnetic resonance imaging using arterial spin labelling, functional connectivity, diffusion tensor imaging, magnetic resonance spectroscopy to evaluate women with chronic pelvic pain and/ or endometriosis

Other: Functional magnetic resonance imaging

Interventions

Functional magnetic resonance imagingOTHER

3 Tesla magnetic resonance imaging

Also known as: FMRI
Magnetic resonance imaging

Eligibility Criteria

Age21 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic pelvic pain
  • Endometriosis

You may not qualify if:

  • Contraindication to magnetic resonance imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

MeSH Terms

Conditions

AdenomyosisEndometriosis

Condition Hierarchy (Ancestors)

Uterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Ban L Sng, FANZCA

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2014

First Posted

June 10, 2014

Study Start

June 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

SG(1)