- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04028804
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 1X8
- The Hospital for Sick Children
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients who are pregnant or nursing
- Medically unstable or critically ill
- Lack of informed consent
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
FDG PET
FDG PET imagaing
|
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.
Other Names:
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.
Other Names:
|
FLT PET
FLT PET imaging
|
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.
Other Names:
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amer Shammas, Md, The Hospital for Sick Children
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Hodgkin Disease
- Lymphoma, Non-Hodgkin
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Protective Agents
- Cariostatic Agents
- Fluorides
- Deoxyglucose
Other Study ID Numbers
- 1000021766
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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