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出境医 / 临床实验 / FLT PET: A Pilot Study in Lymphoma Patients
FLT PET: A Pilot Study in Lymphoma Patients
Study Description
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Hodgkin's Lymphoma Non-Hodgkin's Lymphoma | Procedure: FDG PET Procedure: FLT PET |
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
| Study Type : | Observational |
| Actual Enrollment : | 8 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Prospective |
| Official Title: | Imaging Cell Proliferation With FLT PET: A Pilot Study in Paediatric Lymphoma Patients With Equivocal FDG PET Findings |
| Study Start Date : | July 2011 |
| Actual Primary Completion Date : | December 2014 |
| Actual Study Completion Date : | December 2014 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
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 Name: 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 Name: 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 Name: 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 Name: 3'-deoxy-3'-[fluorine-18]-fluorothymidine (FLT)
|
Outcome Measures
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- 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.
Eligibility Criteria
| Ages Eligible for Study: | up to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Pediatric lymphoma
Criteria
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
Contacts and Locations
Locations
| Canada, Ontario | |
| The Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
| Principal Investigator: | Amer Shammas, Md | The Hospital for Sick Children |
| Tracking Information | ||||
|---|---|---|---|---|
| First Submitted Date | May 12, 2014 | |||
| First Posted Date | July 23, 2019 | |||
| Last Update Posted Date | July 23, 2019 | |||
| Study Start Date | July 2011 | |||
| Actual Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
| Current Primary Outcome Measures |
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
|
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| Original Primary Outcome Measures | Same as current | |||
| Change History | No Changes Posted | |||
| Current Secondary Outcome Measures |
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.
|
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| Original Secondary Outcome Measures | Same as current | |||
| Current Other Pre-specified Outcome Measures | Not Provided | |||
| Original Other Pre-specified Outcome Measures | Not Provided | |||
| Descriptive Information | ||||
| Brief Title | FLT PET: A Pilot Study in Lymphoma Patients | |||
| Official Title | Imaging Cell Proliferation With FLT PET: A Pilot Study in Paediatric Lymphoma Patients With Equivocal FDG PET Findings | |||
| 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. | |||
| 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. |
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| Study Type | Observational | |||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Pediatric lymphoma | |||
| Condition |
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| Intervention |
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| Study Groups/Cohorts |
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| Publications * | Not Provided | |||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment |
8 | |||
| Original Actual Enrollment | Same as current | |||
| Actual Study Completion Date | December 2014 | |||
| Actual Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | up to 18 Years (Child, Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Canada | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT04028804 | |||
| Other Study ID Numbers | 1000021766 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Amer Shammas, The Hospital for Sick Children | |||
| Study Sponsor | The Hospital for Sick Children | |||
| Collaborators | Not Provided | |||
| Investigators |
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| PRS Account | The Hospital for Sick Children | |||
| Verification Date | July 2019 | |||
