NCT01745874

Brief Summary

The purpose of this study is to determine whether whole-body MRI (WB-MRI) accuracy is superior to FDG-PET-CT considered as the gold-standard for the staging of distant lesions of rectal cancer.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 10, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

December 10, 2012

Status Verified

December 1, 2012

Enrollment Period

1 year

First QC Date

December 2, 2012

Last Update Submit

December 7, 2012

Conditions

Rectal Cancer

Keywords

Rectal cancerWhole-body MRIFDG-PET-CTpreoperative staging

Outcome Measures

Primary Outcomes (1)

  • Evaluate the diagnostic accuracy of whole-body MRI for the staging of rectal cancer before and after neoadjuvant treatment

    We will compare for each body region the findings of the whole-body MRI to the FDG-PET-CT considered as the gold-standard and measure sensibility/specificity and diagnostic accuracy of the whole-body MRI for distant lesions of rectal cancer.

    baseline and 1 week before surgery

Secondary Outcomes (1)

  • Tumoral regression after neoadjuvant treatment

    baseline and six weeks after the end of the neoadjuvant treatment

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with a rectal cancer

You may qualify if:

  • rectal cancer T3 N+ or T3 or T4

You may not qualify if:

  • renal failure
  • allergy to iodinated contrast medium
  • contraindication to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lausanne Hospitals

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Milena Cerny

    University of Lausanne Hospitals

    PRINCIPAL INVESTIGATOR

  • Sabine Schmidt Kobbe, Dr.

    University of Lausanne Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Milena Cerny

Study Record Dates

First Submitted

December 2, 2012

First Posted

December 10, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

December 10, 2012

Record last verified: 2012-12

Locations

CH(1)