FLT PET: A Pilot Study in Lymphoma Patients

July 22, 2019 updated by: Amer Shammas, The Hospital for Sick Children

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 day to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric lymphoma

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
FDG PET
FDG PET imagaing
Procedure: FDG PET
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:
  • 2-[fluorine-18]-fluoro-2-deoxy-D-glucose (FDG)
Procedure: FLT PET
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:
  • 3'-deoxy-3'-[fluorine-18]-fluorothymidine (FLT)
FLT PET
FLT PET imaging
Procedure: FDG PET
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:
  • 2-[fluorine-18]-fluoro-2-deoxy-D-glucose (FDG)
Procedure: FLT PET
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:
  • 3'-deoxy-3'-[fluorine-18]-fluorothymidine (FLT)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital for Sick Children

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amer Shammas, Md, The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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