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Combined CT Colonography and PET Imaging in Mantle Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT00541424
Recruitment Status : Withdrawn (No study recruitment due to time constraints and lack of support.)
First Posted : October 10, 2007
Last Update Posted : December 6, 2012
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

The goal of this clinical research study is to learn if positron emission tomography (PET)/computed tomography (CT) scanning can be used to detect mantle cell lymphoma in the colon. Researchers want to learn if PET/CT scanning can produce good-quality images and/or find the exact locations of lymphoma in the body.

Primary Objective is to determine if combined CT colonography and full body PET scan is technically feasible and can produce diagnostic scans as well as accurate anatomic coordination for detection of mantle cell lymphoma involvement of the colon.


Condition or disease Intervention/treatment
Mantle Cell Lymphoma Lymphoma Procedure: PET/CT Scanning

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Feasibility of Combined CT Colonography and PET Imaging for Detection of Colonic Involvement by Mantle Cell Lymphoma
Study Start Date : September 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

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U.S. FDA Resources

Group/Cohort Intervention/treatment
PET/CT Scanning
Patients that have newly diagnosed mantle cell lymphoma will first undergo CT colonography (CT or CTC) and PET followed by conventional colonoscopy.
Procedure: PET/CT Scanning
Full-body PET/CT procedure will be performed. Gas will be pumped into the colon before the scan so the colon will be opened up (inflated) and the study doctor will be able to more easily look for any lesions. This procedure is called gas insufflation.



Primary Outcome Measures :
  1. Number of Participants with PET/CT Scan Detection of Mantle Cell Lymphoma [ Time Frame: 1 Day, Participation completed day of CT colonography and full body PET scan ]

Secondary Outcome Measures :
  1. Number of PET/CT Scanning Images Locating Exact Lymphoma Locations [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients that have newly diagnosed mantle cell lymphoma.
Criteria

Inclusion Criteria:

  • Patients who have newly diagnosed mantle cell lymphoma who are already scheduled for standard PET/CT and colonoscopy as part of their staging.
  • Adults (>18 years of age)

Exclusion Criteria:

  • Known diabetes
  • Known complete colonic obstruction
  • Known small bowel obstruction
  • Known anorectal stenosis or acute inflammatory disease or rectal prolapse.
  • Active colitis or diverticulitis
  • Known radiation in the last 2 weeks
  • Known endoscopic hot forceps biopsy in the last 2 weeks
  • Known rectal incontinence
  • Tachypnea or respiratory distress
  • Known end or loop colostomy or ileostomy
  • Contraindications to colonoscopy, including bleeding diathesis; contraindications to sedation because of allergy or respiratory compromise.
  • Patients who are pregnant
  • Diarrhea within the past week
  • Currently participating in chemotherapy treatment

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): NCT00541424


Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Revathy B. Iyer, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00541424     History of Changes
Other Study ID Numbers: 2006-1112
First Posted: October 10, 2007    Key Record Dates
Last Update Posted: December 6, 2012
Last Verified: December 2012

Keywords provided by M.D. Anderson Cancer Center:
Mantle Cell Lymphoma
Lymphoma
CT Colonography
PET Scan
PET/CT Scan
Gas Insufflation

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin