NCT00302094

Brief Summary

CT-examinations are used in computer programs which are used in the planning of external radiation of cancers in the anal canal. In CT the structures of the anal canal are hardly visible. 3D-ultrasound examinations offer a better visualisation of normal and pathological structures of the anal canal. The description of the tumour made from the 3D-ultrasound examination is used in the planning of the external radiation. PET-CT is used to visualise tumour activity also in lymp nodes. The hypothesis of the study is that image fusion of PET, CT and 3D-ultrasound will offer better visualisation of tumour and hereby more accurate diagnostics and treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2006

Typical duration for all trials

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

First Submitted

Initial submission to the registry

March 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

December 3, 2012

Status Verified

November 1, 2012

Enrollment Period

2.8 years

First QC Date

March 10, 2006

Last Update Submit

November 29, 2012

Conditions

Anal Cancer

Outcome Measures

Primary Outcomes (1)

  • Program to fuse 3D ultrasound and PET/CT data

    april 2009

Eligibility Criteria

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

Patients with anal cancer

You may qualify if:

  • Histologically verified cancer of the anal canal

You may not qualify if:

  • Pregnancy
  • Unability to cooperate to radiation therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of Radiology, Section of Ultrasound, Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

Rectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal Diseases

Study Officials

  • Michael B Nielsen, Dmsci, phd.

    Rigshospitalet, Denmark

    STUDY DIRECTOR

  • Caroline Ewertsen, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 10, 2006

First Posted

March 13, 2006

Study Start

June 1, 2006

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

December 3, 2012

Record last verified: 2012-11

Locations

DK(1)