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Combined CT Colonography and PET Imaging in Mantle Cell Lymphoma

This study has been withdrawn prior to enrollment.
(No study recruitment due to time constraints and lack of support.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00541424
First received: October 8, 2007
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

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 Intervention
Mantle Cell Lymphoma
Lymphoma
 Procedure: PET/CT Scanning

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of PET/CT Scanning Images Locating Exact Lymphoma Locations [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541424

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

Additional Information:
MD Anderson Cancer Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00541424     History of Changes
Other Study ID Numbers: 2006-1112
Study First Received: October 8, 2007
Last Updated: December 5, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013