FLT PET: A Pilot Study in Lymphoma Patients
Imaging Cell Proliferation With FLT PET: A Pilot Study in Paediatric Lymphoma Patients With Equivocal FDG PET Findings
1 other identifier
observational
8
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 12, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFirst Posted
Study publicly available on registry
July 23, 2019
CompletedJuly 23, 2019
July 1, 2019
3.4 years
May 12, 2014
July 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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
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
Study Arms (2)
FDG PET
FDG PET imagaing
FLT PET
FLT PET imaging
Interventions
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.
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.
Eligibility Criteria
Pediatric lymphoma
You may qualify if:
- 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.
You may not qualify if:
- Patients who are pregnant or nursing
- Medically unstable or critically ill
- Lack of informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amer Shammas, Md
The Hospital for Sick Children
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nuclear Medicine Radiologist
Study Record Dates
First Submitted
May 12, 2014
First Posted
July 23, 2019
Study Start
July 1, 2011
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
July 23, 2019
Record last verified: 2019-07