Mantle Cell LymphomaNCT00541424
Combined CT Colonography and PET Imaging in Mantle Cell Lymphoma
An observational study of Mantle Cell Lymphoma and Lymphoma, run by M.D. Anderson Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma, Lymphoma
- What is being tested?
- PET/CT Scanning
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Nov 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that have newly diagnosed mantle cell lymphoma.
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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
About this study
Official title: Feasibility of Combined CT Colonography and PET Imaging for Detection of Colonic Involvement by Mantle Cell Lymphoma
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.
Read the detailed description
Colonoscopy Testing:
A colonoscopy is a routine test where the doctor looks at the inner lining of the colon using a long, flexible, lighted tube that is inserted through the anus. This is the standard procedure for detecting mantle cell lymphoma in the colon.
PET/CT Scanning:
Because PET/CT scanning is less invasive than colonoscopy, researchers want to learn more about whether PET/CT scanning may be able to be used for detecting mantle cell lymphoma in the colon.
PET/CT scanning is also considered a routine test for checking the status of mantle cell lymphoma. The scan is called "full body" because the neck, chest, abdomen (stomach area), and pelvis are included.
In this study, participants will have a full-body PET/CT procedure performed like they normally would, but the difference will be that gas will be pumped into the colon before the scan. This is so the colon will be opened up (inflated) so the study doctor will be able to more easily look for any lesions. The procedure is called gas insufflation. (In standard PET/CT scanning of the colon, gas insufflation is not used.)
Study Participation:
If you agree to take part in this study, you will begin the PET/CT procedure, as usual. This means a special substance called fluorodeoxyglucose will be injected by vein, in order to make the tumor more visible in the scanned image.
About an hour later, the study doctor will prepare your colon for the PET/CT scan by performing gas insufflation. To do so, a soft plastic tube will be inserted through your anus. Carbon dioxide gas will be automatically pumped into your colon until the gas is at the correct pressure.
If the study doctor decides it is necessary (for example, if cramping occurs), you will receive a glucagon injection under the skin in order to relax the colon. Glucagon is a medication that helps to relax the colon and decrease cramping. If continued cramping occurs, the gas will be turned off which results in immediate relief. This is considered routine for the CT part of the PET/CT. Administering the gas for the CT is similar to the sensation that will be felt during the colonoscopy when the colon is also insufflated.
After the gas insufflation, the routine PET/CT scan will be performed to check the status of the disease. You will lie on your stomach for the first part of the PET/CT scan and on your back for the second part.
After the PET/CT scan, the routine colonoscopy will be performed. You will need to sign a separate consent form for the colonoscopy, and the procedure will be explained to you in detail.
Length of Study:
Your participation in this study will be over after the PET/CT scan. Researchers will compare the results of the PET/CT scan to the results of the colonoscopy.
This is an investigational study. Gas insufflation and glucagon are FDA approved for use with CT colonography (colonoscopy that uses CT scanning), which is typically used to screen for colon cancer. PET/CT scanning is FDA approved for use in checking the status of mantle cell lymphoma. Using PET/CT scanning to detect mantle cell lymphoma in the colon, however, is investigational. For this purpose, at this time PET/CT scanning is being used in research only.
Up to 43 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Mantle Cell Lymphoma, Lymphoma
- Being tested
- PET/CT Scanning
- Keywords
- Mantle Cell Lymphoma, Lymphoma, CT Colonography, PET Scan, PET/CT Scan, Gas Insufflation
- Medical subject headings
- Lymphoma, Mantle-Cell, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/CT ScanningProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: PET/CT Scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with PET/CT Scan Detection of Mantle Cell Lymphoma
Measured: 1 Day, Participation completed day of CT colonography and full body PET scan
Secondary outcomes (1)
Number of PET/CT Scanning Images Locating Exact Lymphoma Locations
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: No study recruitment due to time constraints and lack of support.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Revathy B. Iyer, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541424
- Sponsor's protocol ID
- 2006-1112
- Status last verified
- Dec 2012
- First submitted
- 8 Oct 2007
- Last updated
- 6 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Combined CT Colonography and PET Imaging for Detection of Colonic Involvement by Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00541424
- Acronym / sponsor ID
- 2006-1112
- Conditions
- Mantle Cell Lymphoma, Lymphoma
- Keywords
- Mantle Cell Lymphoma, Lymphoma, CT Colonography, PET Scan, PET/CT Scan, Gas Insufflation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No study recruitment due to time constraints and lack of support.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 10 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Colonoscopy Testing:
A colonoscopy is a routine test where the doctor looks at the inner lining of the colon using a long, flexible, lighted tube that is inserted through the anus. This is the standard procedure for detecting mantle cell lymphoma in the colon.
PET/CT Scanning:
Because PET/CT scanning is less invasive than colonoscopy, researchers want to learn more about whether PET/CT scanning may be able to be used for detecting mantle cell lymphoma in the colon.
PET/CT scanning is also considered a routine test for checking the status of mantle cell lymphoma. The scan is called "full body" because the neck, chest, abdomen (stomach area), and pelvis are included.
In this study, participants will have a full-body PET/CT procedure performed like they normally would, but the difference will be that gas will be pumped into the colon before the scan. This is so the colon will be opened up (inflated) so the study doctor will be able to more easily look for any lesions. The procedure is called gas insufflation. (In standard PET/CT scanning of the colon, gas insufflation is not used.)
Study Participation:
If you agree to take part in this study, you will begin the PET/CT procedure, as usual. This means a special substance called fluorodeoxyglucose will be injected by vein, in order to make the tumor more visible in the scanned image.
About an hour later, the study doctor will prepare your colon for the PET/CT scan by performing gas insufflation. To do so, a soft plastic tube will be inserted through your anus. Carbon dioxide gas will be automatically pumped into your colon until the gas is at the correct pressure.
If the study doctor decides it is necessary (for example, if cramping occurs), you will receive a glucagon injection under the skin in order to relax the colon. Glucagon is a medication that helps to relax the colon and decrease cramping. If continued cramping occurs, the gas will be turned off which results in immediate relief. This is considered routine for the CT part of the PET/CT. Administering the gas for the CT is similar to the sensation that will be felt during the colonoscopy when the colon is also insufflated.
After the gas insufflation, the routine PET/CT scan will be performed to check the status of the disease. You will lie on your stomach for the first part of the PET/CT scan and on your back for the second part.
After the PET/CT scan, the routine colonoscopy will be performed. You will need to sign a separate consent form for the colonoscopy, and the procedure will be explained to you in detail.
Length of Study:
Your participation in this study will be over after the PET/CT scan. Researchers will compare the results of the PET/CT scan to the results of the colonoscopy.
This is an investigational study. Gas insufflation and glucagon are FDA approved for use with CT colonography (colonoscopy that uses CT scanning), which is typically used to screen for colon cancer. PET/CT scanning is FDA approved for use in checking the status of mantle cell lymphoma. Using PET/CT scanning to detect mantle cell lymphoma in the colon, however, is investigational. For this purpose, at this time PET/CT scanning is being used in research only.
Up to 43 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/CT Scanning | – | Procedure: PET/CT ScanningPatients that have newly diagnosed mantle cell lymphoma will first undergo CT colonography (CT or CTC) and PET followed by conventional colonoscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have newly diagnosed mantle cell lymphoma.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (14 listed)
- Known diabetes
- Known complete colonic obstruction
- Known small bowel obstruction
- Known anorectal stenosis or acute inflammatory disease or rectal prolapse.
- Active colitis or diverticulitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/CT ScanningFull-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. | Procedure or surgery | PET/CT Scanning |
Primary outcome
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
1 secondary outcome
Number of PET/CT Scanning Images Locating Exact Lymphoma Locations
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2012.
- MD Anderson Cancer CenterLink provided by the sponsor.
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A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
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RecruitingPhase 2
Auto Stem Cell Transplant for Lymphoma Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Revathy B. Iyer, MD principal investigator
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Mantle Cell Lymphoma and Lymphoma, run by M.D. Anderson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2012.