Image Fusion PET, CT and 3D-ultrasound Examinations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Caroline Ewertsen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00302094
First received: March 10, 2006
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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.


Condition
Anal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Image Fusion PET, CT and 3D-ultrasound Examinations in Treatment of Anal Cancer

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Program to fuse 3D ultrasound and PET/CT data [ Time Frame: april 2009 ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: June 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with anal cancer

Criteria

Inclusion Criteria:

  • Histologically verified cancer of the anal canal

Exclusion Criteria:

  • Pregnancy
  • Unability to cooperate to radiation therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302094

Locations
Denmark
Clinic of Radiology, Section of Ultrasound, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Director: Michael B Nielsen, Dmsci, phd. Rigshospitalet, Denmark
Principal Investigator: Caroline Ewertsen, MD Rigshospitalet, Denmark
  More Information

No publications provided

Responsible Party: Caroline Ewertsen, MD, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00302094     History of Changes
Other Study ID Numbers: (KF) 11-107/03
Study First Received: March 10, 2006
Last Updated: November 29, 2012
Health Authority: Denmark: Videnskabsetisk Komité

Additional relevant MeSH terms:
Anus Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 26, 2014