Non-Hodgkin's LymphomaNCT00775957
Assessment of Hematopoietic Recovery Following Chemotherapy for Non-Hodgkin's Lymphoma
An observational study of Non-Hodgkin's Lymphoma, run by University of Oklahoma at 1 site in United States.
Trial summary
A study to determine the accuracy of FLT-PET in quantifying tumor cell proliferation at the initial staging of patients with Non-Hodgkin's Lymphoma in comparison wit the "gold standard" FDG-PET. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- FLT-PET scan and FDG-PET scan
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to not given
- 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: Subjects diagnosed with lymphoma and are about to start treatment with chemotherapy
Who may be able to join
- 18 years or older
- Women must not be pregnant or breast feeding
- Histologic diagnosis of non-Hodgkin's lymphoma (any stage)
- Must undergo treatment with chemotherapy and/or radiotherapy
Who cannot join
- May not have received previous therapy with radiopharmaceuticals
- May not have received prior therapy with cytotoxic chemotherapy and/or monoclonal antibodies
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Assessment of Hematopoietic Recovery Following Chemotherapy for Non-Hodgknin's Lymphoma
A study to determine the accuracy of FLT-PET in quantifying tumor cell proliferation at the initial staging of patients with Non-Hodgkin's Lymphoma in comparison wit the "gold standard" FDG-PET.
Read the detailed description
The first primary objective reflects a necessary and preliminary requirement: to reproduce published results and validate the use of FLT-PET. In this study, 35 patients will be selected to undergoing imaging with both FLT and FDG PET.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- FLT-PET scan, FDG-PET scan
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLT-PET scanProcedure or surgery
imaging scan
FDG-PET scanProcedure or surgery
imaging scan
| Study group | Role | What they receive |
|---|---|---|
| 1 | FLT-PET Scan Receives: Procedure: FLT-PET scan | |
| 2 | FDG-PET Scan Receives: Procedure: FDG-PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Staging and ReStaging scans
Measured: after hematopoetic recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2008 (estimated)
- Study startOct 2008
Why it stopped: Terminated by institutional review board
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Midwest Medical Isotopes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775957
- Sponsor's protocol ID
- FLT-NHL
- Status last verified
- Sep 2010
- First submitted
- 17 Oct 2008
- Last updated
- 28 Sep 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hematopoietic Recovery Following Chemotherapy for Non-Hodgknin's Lymphoma
- ClinicalTrials.gov ID
- NCT00775957
- Acronym / sponsor ID
- FLT-NHL
- Conditions
- Non-Hodgkin's Lymphoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminated by institutional review board
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Midwest Medical Isotopes
- Study start
- Oct 2008
- First posted
- 20 Oct 2008 (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.
A study to determine the accuracy of FLT-PET in quantifying tumor cell proliferation at the initial staging of patients with Non-Hodgkin's Lymphoma in comparison wit the "gold standard" FDG-PET.
Detailed description
The first primary objective reflects a necessary and preliminary requirement: to reproduce published results and validate the use of FLT-PET. In this study, 35 patients will be selected to undergoing imaging with both FLT and FDG PET.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: FLT-PET scanFLT-PET Scan |
| 2 | – | Procedure: FDG-PET scanFDG-PET Scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed with lymphoma and are about to start treatment with chemotherapy
Key inclusion criteria (4 listed)
- 18 years or older
- Women must not be pregnant or breast feeding
- Histologic diagnosis of non-Hodgkin's lymphoma (any stage)
- Must undergo treatment with chemotherapy and/or radiotherapy
Key exclusion criteria (2 listed)
- May not have received previous therapy with radiopharmaceuticals
- May not have received prior therapy with cytotoxic chemotherapy and/or monoclonal antibodies
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 |
|---|---|---|
| FLT-PET scanimaging scan | Procedure or surgery | 1 |
| FDG-PET scanimaging scan | Procedure or surgery | 2 |
Primary outcome
Staging and ReStaging scans
Time frame: after hematopoetic recovery
Results and safety
The study was stopped early (reason given: Terminated by institutional review board). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Hodgkin's Lymphoma, run by University of Oklahoma at 1 site in United States.
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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 28 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Terminated by institutional review board). Results are not available in the source record.
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?
Staging and ReStaging scans (time frame: after hematopoetic recovery). 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 28 Sep 2010.