Hodgkin's LymphomaNCT04028804
FLT PET: A Pilot Study in Lymphoma Patients
An observational study of Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Background: Residual masses on follow-up surveillance imaging are frequently detected in paediatric patients with Hodgkin's lymphoma and non-Hodgkin's lymphoma. The residual mass may consist of inflammatory, fibrous or necrotic tissue, or it could represent residual tumor. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
- What is being tested?
- FDG PET and FLT PET
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Dec 2014
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric lymphoma
Who may be able to join
- SickKids Hospital patient of any gender or race
- Participants who are able to undergo imaging procedures without general anaesthesia or sedation
- Patient's or the patient's parents'/guardians' written informed consent prior to participation
- Previous FDG PET scan with at least one documented equivocal finding (i.e. SUV ≥ 2.0, but < 3.5) and no other finding(s) that is strongly suggestive of malignancy. The lesion(s) must have a minimum size of 1 cm in diameter by any CIM in order to address the spatial resolution limitations of the PET scanner.
Who cannot join
- Patients who are pregnant or nursing
- Medically unstable or critically ill
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Imaging Cell Proliferation With FLT PET: A Pilot Study in Paediatric Lymphoma Patients With Equivocal FDG PET Findings
Background: Residual masses on follow-up surveillance imaging are frequently detected in paediatric patients with Hodgkin's lymphoma and non-Hodgkin's lymphoma. The residual mass may consist of inflammatory, fibrous or necrotic tissue, or it could represent residual tumor. In most cases, positron emission tomography (PET) with 2-[fluorine-18]-fluoro-2-deoxy-D-glucose (FDG) is useful for distinguishing tumor from fibrosis. However, FDG is not tumor-specific, and increased accumulation of the tracer may be seen in a variety of benign entities which can give rise to false-positive or equivocal FDG PET findings. Alternatively, the uptake of 3'-deoxy-3'-[fluorine-18]-fluorothymidine (FLT) reflects cellular proliferation, and may prove to be a reliable method in resolving equivocal FDG PET findings. Indeed, several studies have demonstrated that FLT can be safely administered to children, and in some cases be more useful than FDG PET in differentiating between infection or inflammation and malignancy. This study hypothesizes that FLT PET can be used as an adjunct imaging modality in paediatric lymphoma patients with equivocal interim or post-therapy FDG PET findings, and that this technique can provide additional diagnostic information which will be useful in distinguishing fibrotic or necrotic residual mass lesions from those that may be harbouring malignancy.
Read the detailed description
This is a prospective pilot study evaluating the clinical use of FLT PET in paediatric patients with Hodgkin's lymphoma (HL) or non-Hodgkin's lymphoma (NHL). The overall objective of this trial is to assess the feasibility of using FLT PET as an adjunct imaging modality to follow-up paediatric lymphoma patients whose interim or post-therapy FDG PET scan is interpreted as being equivocal. The primary outcome measure is to obtain a preliminary estimate of the diagnostic performance (including the sensitivity, specificity and accuracy) of adjunct FLT PET. This pilot study will yield sufficient preliminary data to help justify and design a subsequent larger study of FLT PET in paediatric lymphoma patients.
This study is open only to HL and NHL patients whose interim or post-therapy FDG PET scan is interpreted as being equivocal and in whom it is not possible resolve the exam results using other conventional imaging techniques such as CT or MRI. All FLT PET image findings will be presented to the treating physician(s) responsible for managing the care of any patient enrolled in this trial. Treating physicians will continue to use routine practices to resolve equivocal FDG PET findings.
- Conditions
- Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
- Being tested
- FDG PET, FLT PET
- Keywords
- Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Possitron Emission Therapy (PET), FDG PET, FLT PET, Pediatrics
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDG PETProcedure or surgery
Also called 2-[fluorine-18]-fluoro-2-deoxy-D-glucose (FDG)
Each patient will receive a single intravenous injection of FDG (5.18 MBq/kg (0.14 mCi/kg)) using a minimum dose of 37 MBq (1 mCi) up to a maximum of 370 MBq (10 mCi) with an accepted 10%-20% variation since dose variation can occur when small concentrated volumes of FDG are being drawn up or radioactive decay has reduced the amount of available.
FLT PETProcedure or surgery
Also called 3'-deoxy-3'-[fluorine-18]-fluorothymidine (FLT)
The FLT PET scan will be performed 1-5 days after FDG PET in order to ensure consistency between imaging findings. Each patient will receive a single intravenous injection of FLT (5.18 MBq/kg (0.14 mCi/kg)) using a minimum dose of 37 MBq (1 mCi) up to a maximum of 370 MBq (10 mCi) with an accepted 10%-20% variation since dose variation can occur when small concentrated volumes of FLT are being drawn up or radioactive decay has reduced the amount of available.
| Study group | Role | What they receive |
|---|---|---|
| FDG PET | FDG PET imagaing Receives: Procedure: FDG PET; Procedure: FLT PET | |
| FLT PET | FLT PET imaging Receives: Procedure: FDG PET; Procedure: FLT PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Performing FLT PET Imaging: SUVs values
To assess the feasibility of performing 3'-deoxy-3'-[fluorine-18]-fluorothymidine positron emission tomography (FLT PET) imaging.
The investigator's goals were to assess the normal tissue distribution of 18F-FLT and to provide standardized uptake values (SUVs) of lesions demonstrating equivocal uptake on 18F-FDG PET/CT and compare SUVs values of FLT and FDG
Measured: FLT PET performed within 1-5 days of FDG PET. PET/CT image findings were compared in relation to pathology within 1 month (when tissue sampling was performed), additional cross-sectional imaging, and/or clinical follow-up for at least 3 months.
Secondary outcomes (1)
Diagnostic Performance
To obtain a preliminary estimate of the diagnostic performance of adjunct 3'-deoxy-3'-[fluorine-18]-fluorothymidine positron emission tomography (FLT PET) in identifying malignant Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma lesions which receive an equivocal diagnosis by 2-[fluorine-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG PET). Provide standardized uptake values (SUVs) of lesions demonstrating equivocal uptake on 18F-FDG PET/CT.
Measured: PET/CT image findings were compared in relation to pathology within 1 month (when tissue sampling was performed), additional cross-sectional imaging, and/or clinical follow-up for at least 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2019
- Study startJul 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amer Shammas, The Hospital for Sick Children
- Investigators
- Amer Shammas, Md, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028804
- Sponsor's protocol ID
- 1000021766
- Status last verified
- Jul 2019
- First submitted
- 12 May 2014
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging Cell Proliferation With FLT PET: A Pilot Study in Paediatric Lymphoma Patients With Equivocal FDG PET Findings
- ClinicalTrials.gov ID
- NCT04028804
- Acronym / sponsor ID
- 1000021766
- Conditions
- Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma
- Keywords
- Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Possitron Emission Therapy (PET), FDG PET, FLT PET, Pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Jul 2019 (actual)
- 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.
Background: Residual masses on follow-up surveillance imaging are frequently detected in paediatric patients with Hodgkin's lymphoma and non-Hodgkin's lymphoma. The residual mass may consist of inflammatory, fibrous or necrotic tissue, or it could represent residual tumor. In most cases, positron emission tomography (PET) with 2-[fluorine-18]-fluoro-2-deoxy-D-glucose (FDG) is useful for distinguishing tumor from fibrosis. However, FDG is not tumor-specific, and increased accumulation of the tracer may be seen in a variety of benign entities which can give rise to false-positive or equivocal FDG PET findings. Alternatively, the uptake of 3'-deoxy-3'-[fluorine-18]-fluorothymidine (FLT) reflects cellular proliferation, and may prove to be a reliable method in resolving equivocal FDG PET findings. Indeed, several studies have demonstrated that FLT can be safely administered to children, and in some cases be more useful than FDG PET in differentiating between infection or inflammation and malignancy. This study hypothesizes that FLT PET can be used as an adjunct imaging modality in paediatric lymphoma patients with equivocal interim or post-therapy FDG PET findings, and that this technique can provide additional diagnostic information which will be useful in distinguishing fibrotic or necrotic residual mass lesions from those that may be harbouring malignancy.
Detailed description
This is a prospective pilot study evaluating the clinical use of FLT PET in paediatric patients with Hodgkin's lymphoma (HL) or non-Hodgkin's lymphoma (NHL). The overall objective of this trial is to assess the feasibility of using FLT PET as an adjunct imaging modality to follow-up paediatric lymphoma patients whose interim or post-therapy FDG PET scan is interpreted as being equivocal. The primary outcome measure is to obtain a preliminary estimate of the diagnostic performance (including the sensitivity, specificity and accuracy) of adjunct FLT PET. This pilot study will yield sufficient preliminary data to help justify and design a subsequent larger study of FLT PET in paediatric lymphoma patients.
This study is open only to HL and NHL patients whose interim or post-therapy FDG PET scan is interpreted as being equivocal and in whom it is not possible resolve the exam results using other conventional imaging techniques such as CT or MRI. All FLT PET image findings will be presented to the treating physician(s) responsible for managing the care of any patient enrolled in this trial. Treating physicians will continue to use routine practices to resolve equivocal FDG PET findings.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FDG PET | – | Procedure: FDG PET, Procedure: FLT PETFDG PET imagaing |
| FLT PET | – | Procedure: FDG PET, Procedure: FLT PETFLT PET imaging |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric lymphoma
Key inclusion criteria (4 listed)
- SickKids Hospital patient of any gender or race
- Participants who are able to undergo imaging procedures without general anaesthesia or sedation
- Patient's or the patient's parents'/guardians' written informed consent prior to participation
- Previous FDG PET scan with at least one documented equivocal finding (i.e. SUV ≥ 2.0, but < 3.5) and no other finding(s) that is strongly suggestive of malignancy. The lesion(s) must have a minimum size of 1 cm in diameter by any CIM in order to address the spatial resolution limitations of the PET scanner.
Key exclusion criteria (3 listed)
- Patients who are pregnant or nursing
- Medically unstable or critically ill
- Lack of informed consent
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 |
|---|---|---|
| FDG PETAlso: 2-[fluorine-18]-fluoro-2-deoxy-D-glucose (FDG)Each patient will receive a single intravenous injection of FDG (5.18 MBq/kg (0.14 mCi/kg)) using a minimum dose of 37 MBq (1 mCi) up to a maximum of 370 MBq (10 mCi) with an accepted 10%-20% variation since dose variation can occur when small concentrated volumes of FDG are being drawn up or radioactive decay has reduced the amount of available. | Procedure or surgery | FDG PET, FLT PET |
| FLT PETAlso: 3'-deoxy-3'-[fluorine-18]-fluorothymidine (FLT)The FLT PET scan will be performed 1-5 days after FDG PET in order to ensure consistency between imaging findings. Each patient will receive a single intravenous injection of FLT (5.18 MBq/kg (0.14 mCi/kg)) using a minimum dose of 37 MBq (1 mCi) up to a maximum of 370 MBq (10 mCi) with an accepted 10%-20% variation since dose variation can occur when small concentrated volumes of FLT are being drawn up or radioactive decay has reduced the amount of available. | Procedure or surgery | FDG PET, FLT PET |
Primary outcome
Feasibility of Performing FLT PET Imaging: SUVs values
Time frame: FLT PET performed within 1-5 days of FDG PET. PET/CT image findings were compared in relation to pathology within 1 month (when tissue sampling was performed), additional cross-sectional imaging, and/or clinical follow-up for at least 3 months.
To assess the feasibility of performing 3'-deoxy-3'-[fluorine-18]-fluorothymidine positron emission tomography (FLT PET) imaging. The investigator's goals were to assess the normal tissue distribution of 18F-FLT and to provide standardized uptake values (SUVs) of lesions demonstrating equivocal uptake on 18F-FDG PET/CT and compare SUVs values of FLT and FDG
1 secondary outcome
Diagnostic Performance
Time frame: PET/CT image findings were compared in relation to pathology within 1 month (when tissue sampling was performed), additional cross-sectional imaging, and/or clinical follow-up for at least 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
Related trials for Hodgkin's Lymphoma
RecruitingPhase 1/2
A Study to Evaluate Safety and Clinical Activity of GSK5926371 in Adult Participants With Relapsed or Refractory B-NHL
Lymphoma, Non-Hodgkin
RecruitingPhase 1
Belinostat in Combination With Azacitidine or Pralatrexate for the Treatment of Relapse or Refractory T-cell Lymphoma
Recurrent Anaplastic Large Cell Lymphoma, Recurrent Enteropathy-Associated T-Cell Lymphoma
Active, not recruitingObservational study
Clinical, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Hematologic Cancer
Waldenstrom Macroglobulinemia, Chronic Lymphocytic Leukemia
RecruitingObservational study
Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
Hematologic Malignancy, Leukemia
Active, not recruitingPhase 1/2
Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas
Anaplastic Large Cell Lymphoma, Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
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.
Amer Shammas, Md principal investigator
The Hospital for Sick Children
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 Hodgkin's Lymphoma and Non-Hodgkin's Lymphoma, run by The Hospital for Sick Children at 1 site in Canada.
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 3 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 23 Jul 2019. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility of Performing FLT PET Imaging: SUVs values (time frame: FLT PET performed within 1-5 days of FDG PET. PET/CT image findings were compared in relation to pathology within 1 month (when tissue sampling was performed), additional cross-sectional imaging, and/or clinical follow-up for at least 3 months.). 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 23 Jul 2019.