LymphomaNCT01004718
Detection and Quant of Differences in Hodgkin Lymphoma and Diffuse Large B-cell Lymphoma Using Positron Emission Tomography/Computed Tomography (PET/CT)
A study testing Fludeoxyglucose F18, Computed Tomography and Positron emission tomography in people with Lymphoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
RATIONALE: Imaging procedures, such as positron emission tomography or computed tomography, may help in detecting differences between Hodgkin lymphoma or diffuse large B-cell lymphoma cancer cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma
- What is being tested?
- Fludeoxyglucose F18, Computed Tomography and Positron emission tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to 5 Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Subjects with a pathologically-proven diagnosis of classic HL or DLBCL with measurable disease by any imaging technique or physical examination.
Who cannot join
- Pregnant or nursing,
- Uncontrolled diabetes mellitus,
- Active infection,
- Inability to give informed consent or to comply with all study procedures,
- Subjects may be excluded at the discretion of the principal investigator or study team members.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Pilot Study to Assess the Feasibility of Detection and Quantification of Differences in Hodgkin Lymphoma and Diffuse Large B-cell Lymphoma Using FDG-PET/CT Imaging
RATIONALE: Imaging procedures, such as positron emission tomography or computed tomography, may help in detecting differences between Hodgkin lymphoma or diffuse large B-cell lymphoma cancer cells. PURPOSE: This clinical trial is studying positron emission tomogaphy and computed tomography in determining differences in Hodgkin lymphoma and diffuse large B-cell lymphoma.
Read the detailed description
OBJECTIVES:
- Assess the feasibility of detection and quantification of differences in the temporal and spatial distribution of FDG uptake between lesions of HL and DLBCL.
OUTLINE:
Patients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans 60 and 180 minutes after FDG administration.
After completion of study, patients are followed for 24 hours.
- Conditions
- Lymphoma
- Being tested
- Fludeoxyglucose F18, Computed Tomography, Positron emission tomography
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fludeoxyglucose F18Radiation
Also called 18FDG, FDG, Fluorine-18, 2 Fluoro-2-deoxy-D-Glucose, Fludeoxyglucose F18
Undergo FDG PET/CT scans
Computed TomographyProcedure or surgery
Also called tomography, computed
Undergo FDG PET/CT scans
Positron emission tomographyProcedure or surgery
Also called FDG-PET, PET, PET scan, tomography, emission computed
Undergo FDG PET/CT scans
| Study group | Role | What they receive |
|---|---|---|
| Fludeoxyglucose F18 (FDG) PET/CT scans | Experimental | Patients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans and 180 minutes after FDG administration. Receives: Radiation: Fludeoxyglucose F18; Procedure: Computed Tomography; Procedure: Positron emission tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in Maximum Lesional FDG Uptake From 60 to 180 Minutes After FDG Administration
Lesional fluorodeoxyglucose (FDG) uptake is measured by standardized uptake value (SUV). The study compared the percentage of change in maximum SUV over 2 hours (first measure was 60 minutes post-administration and second timepoint was 180 minutes post-administration).
Measured: 2 hours (between 60 minutes post-administration and 180 minutes post-administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startMay 2009
- Primary completionJul 2013
- Study completion5 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LymphomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004718
- Sponsor's protocol ID
- UPCC 21408
- Other IDs
- NCI-2009-01348
- Status last verified
- Apr 2021
- First submitted
- 29 Oct 2009
- Last updated
- 18 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Assess the Feasibility of Detection and Quantification of Differences in Hodgkin Lymphoma and Diffuse Large B-cell Lymphoma Using FDG-PET/CT Imaging
- ClinicalTrials.gov ID
- NCT01004718
- Acronym / sponsor ID
- UPCC 21408
- Conditions
- Lymphoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- 5 Nov 2014 (actual)
- First posted
- 30 Oct 2009 (estimated)
- Results
- Posted 18 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Imaging procedures, such as positron emission tomography or computed tomography, may help in detecting differences between Hodgkin lymphoma or diffuse large B-cell lymphoma cancer cells. PURPOSE: This clinical trial is studying positron emission tomogaphy and computed tomography in determining differences in Hodgkin lymphoma and diffuse large B-cell lymphoma.
Detailed description
OBJECTIVES:
- Assess the feasibility of detection and quantification of differences in the temporal and spatial distribution of FDG uptake between lesions of HL and DLBCL.
OUTLINE:
Patients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans 60 and 180 minutes after FDG administration.
After completion of study, patients are followed for 24 hours.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fludeoxyglucose F18 (FDG) PET/CT scans | Experimental | Radiation: Fludeoxyglucose F18, Procedure: Computed Tomography, Procedure: Positron emission tomographyPatients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans and 180 minutes after FDG administration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with a pathologically-proven diagnosis of classic HL or DLBCL with measurable disease by any imaging technique or physical examination.
Key exclusion criteria (5 listed)
- Pregnant or nursing,
- Uncontrolled diabetes mellitus,
- Active infection,
- Inability to give informed consent or to comply with all study procedures,
- Subjects may be excluded at the discretion of the principal investigator or study team members.
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 |
|---|---|---|
| Fludeoxyglucose F18Also: 18FDG, FDG, Fluorine-18, 2 Fluoro-2-deoxy-D-Glucose, Fludeoxyglucose F18Undergo FDG PET/CT scans | Radiation | Fludeoxyglucose F18 (FDG) PET/CT scans |
| Computed TomographyAlso: tomography, computedUndergo FDG PET/CT scans | Procedure or surgery | Fludeoxyglucose F18 (FDG) PET/CT scans |
| Positron emission tomographyAlso: FDG-PET, PET, PET scan, tomography, emission computedUndergo FDG PET/CT scans | Procedure or surgery | Fludeoxyglucose F18 (FDG) PET/CT scans |
Primary outcome
Percentage Change in Maximum Lesional FDG Uptake From 60 to 180 Minutes After FDG Administration
Time frame: 2 hours (between 60 minutes post-administration and 180 minutes post-administration)
Lesional fluorodeoxyglucose (FDG) uptake is measured by standardized uptake value (SUV). The study compared the percentage of change in maximum SUV over 2 hours (first measure was 60 minutes post-administration and second timepoint was 180 minutes post-administration).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Lymphoma
RecruitingPhase 2/3
A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
B-cell Acute Lymphoblastic Leukemia
Active, not recruitingPhase 1/2
Tafasitamab, Retifanlimab, and Rituximab in Combination With Standard Therapy for the Treatment of Diffuse Large B-cell Lymphoma
Diffuse Large B-Cell Lymphoma, Grade 3b Follicular Lymphoma
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
RecruitingPhase 1
225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Recruiting
More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
Acute Lymphatic Leukemia, Lymphoma
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?
A study testing Fludeoxyglucose F18, Computed Tomography and Positron emission tomography in people with Lymphoma, run by Abramson Cancer Center at Penn Medicine 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 18 May 2021. 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?
Yes. Results are posted in the registry (first posted 18 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage Change in Maximum Lesional FDG Uptake From 60 to 180 Minutes After FDG Administration (time frame: 2 hours (between 60 minutes post-administration and 180 minutes post-administration)). 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 18 May 2021.