Combined CT Colonography and PET Imaging in Mantle Cell Lymphoma

This study has been terminated.

( No study recruitment due to time constraints and lack of support. )

First Received: October 8, 2007 Last Updated: March 13, 2009 History of Changes

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00541424

Purpose

Primary Objective:

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:	Case-Only, 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:

MedlinePlus related topics: Cancer Lymphoma Nuclear Scans

U.S. FDA Resources

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

Primary Outcome Measures:

To learn if PET/CT scanning can be used to detect mantle cell lymphoma in the colon. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To learn if PET/CT scanning can produce good-quality images and/or find the exact locations of lymphoma in the body. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

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
1 Patients that have newly diagnosed mantle cell lymphoma.	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

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Revathy B. Iyer, MD

U.T.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:	U.T.M.D. Anderson Cancer Center ( Revathy B. Iyer, MD/Associate Professor )
Study ID Numbers:	2006-1112
Study First Received:	October 8, 2007
Last Updated:	March 13, 2009
ClinicalTrials.gov Identifier:	NCT00541424 History of Changes
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

Study placed in the following topic categories:

Lymphatic Diseases
Immunoproliferative Disorders
Lymphoma, Mantle-Cell
Mantle Cell Lymphoma

Flatulence
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:

Lymphatic Diseases
Neoplasms
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases

Lymphoma, Mantle-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma

ClinicalTrials.gov processed this record on August 28, 2009