Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 81 of 483 for:    colon cancer | ( Map: Texas, United States )

Lesion Detection Assessment in the Liver: Standard vs Low Radiation Dose Using Varied Post-Processing Techniques

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03151564
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is to compare imaging software and 2 different radiation doses during a standard CT scan in order to "see" problems in the liver and still produce a good image quality.

This is an investigational study. The CT scans in this study are performed using an FDA-approved and commercially available method. The comparison of software used in this study at 2 different radiation doses is considered research.

Up to 104 participants will be enrolled in the study. All will take part at MD Anderson.


Condition or disease Intervention/treatment Phase
Diseases of Liver Colon Carcinoma Colorectal Carcinoma Liver Metastases Diagnostic Test: Computed Tomography Scan - 50% Dose Reduction Diagnostic Test: Computed Tomography Scan - 70% Dose Reduction Not Applicable

Detailed Description:

If you agree to take part in this study, you will have a CT scan that is done as part of your routine care. This CT scan will be done at the normal radiation dose.

During this scan, you will also have a scan of the liver at a lower radiation dose, which is part of the research in this study. This will add about a minute to your normal scan time.

Information will also be collected from your medical record.

After your scan, your participation in this study will be over.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Lesion Detection Assessment in the Liver: Standard vs Low Radiation Dose Using Varied Post-Processing Techniques
Actual Study Start Date : May 9, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Computed Tomography Scan - 50% Dose Reduction
Participants undergo routine standard of care CT examination for colon carcinoma restaging, then have an additional scan of the liver at 50% dose reduction.
Diagnostic Test: Computed Tomography Scan - 50% Dose Reduction
Participants undergo routine standard of care CT examination for colon carcinoma restaging, then have an additional scan of the liver at 50% dose reduction.
Other Name: CT scan

Experimental: Computed tomography Scan - 70% Dose Reduction
Participants undergo routine standard of care CT examination for colon carcinoma restaging, then have an additional scan of the liver at 70% dose reduction.
Diagnostic Test: Computed Tomography Scan - 70% Dose Reduction
Participants undergo routine standard of care CT examination for colon carcinoma restaging, then have an additional scan of the liver at 70% dose reduction.
Other Name: CT scan




Primary Outcome Measures :
  1. Metastasis Detection Accuracy [ Time Frame: 1 day ]
    Primary endpoint is metastasis detection accuracy status of each patient, where the standard of care scan reviewed by ''truth readers'' (independent to the blinded radiologists) serve as the gold standard. If any lesion of a patient is diagnosed as metastasis by "truth readers" or blinded readers' consensus, that patient will be considered true positive and diagnosis positive, respectively. The expected accuracy of standard CT is 95%, and a low dose CT detection be considered non-inferior if its accuracy is 85% or higher.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient must be >/= 18 years of age and </=90 years of age
  2. Men and non-pregnant women
  3. Pathology proven diagnosis of colon or colorectal carcinoma
  4. Liver metastases on most recent prior M.D. Anderson CT examination
  5. Standard of care CT abdomen examination planned WITH IV contrast

Exclusion Criteria:

  1. Patients cannot give informed consent
  2. Patients cannot undergo CT examination

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151564


Contacts
Layout table for location contacts
Contact: Corey T. Jensen, MD 713-745-3835 CJensen@mdanderson.org

Locations
Layout table for location information
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Corey T. Jensen, MD       cjensen@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Layout table for investigator information
Principal Investigator: Corey T. Jensen, MD M.D. Anderson Cancer Center

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03151564     History of Changes
Other Study ID Numbers: 2016-1135
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Diseases of liver
Colon carcinoma
Colorectal carcinoma
Liver metastases
Computed tomography
CT
Reduced radiation doses
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Carcinoma
Liver Diseases
Neoplastic Processes
Pathologic Processes
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Liver Extracts
Hematinics