Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123760
Status:
COMPLETED
Last Update Posted:
2016-02-25
First Post:
2005-07-22
Brief Title:
Study of 18F-Fluorodeoxyglucose FluGlucoScan in Patients With Cancer or Suspected Cancer
Sponsor:
AHS Cancer Control Alberta
Organization:
AHS Cancer Control Alberta
Study Overview
Official Title:
A Phase III Phase III and Extended Phase III Study of 18F-Fluorodeoxyglucose FluGlucoScan in Patients With Cancer or Suspected Cancer
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Positron Emission Tomography PET is a specialised nuclear medicine procedure that uses positron emitting radiolabeled tracer molecules to measure biological activity The most common of these radiolabeled tracers is 18F-fluorodeoxyglucose 18F-FDG which is used to determine abnormal glucose metabolism in tumours and other sites It has general applications in all areas where abnormal glucose metabolism may be present including in circumstances such as differentiating the tumour from scar tissue evaluating the presence of the tumour in light of rising tumour markers and normal morphological imaging techniques and assessing response to therapy where other techniques are deemed to be unhelpful The Cross Cancer Institute CCI has recently been funded to establish a PET centre and this study will prove the effectiveness of PET scanning in the Canadian health care environment and validate the data that have been developed in other jurisdictions in specific oncologic indications
Detailed Description:
Background
Positron Emission Tomography PET is a specialised Nuclear Medicine procedure that uses positron emitting radiolabeled tracer molecules to measure biological activity The commonest of these radiolabeled tracers is 18F-Fluorodeoxyglucose 18F-FDG which is used to determine abnormal glucose metabolism in tumours and other sites It has general applications in all areas where abnormal glucose metabolism may be present including circumstances such as differentiating tumour from scar tissue evaluating the presence of tumour in the light of rising tumour markers and normal morphological imaging techniques and assessing response to therapy where other techniques are deemed to be unhelpful
The Cross Cancer Institute has recently been funded to establish a PET centre that will establish a research programme to prove the effectiveness of PET scanning in the Canadian health care environment and validate the data that have been developed in other jurisdictions in specific oncologic indications
Objectives
Primary Objectives - The objectives of the clinical trial are to a demonstrate the safety of 18F-FDG synthesised from cyclotron produced radiofluoride in the Coincidence Technologies automated synthesis unit ASU in the Edmonton PET Centre facility and b confirm the diagnostic effectiveness of 18F-FDG in subjects with known or suspected oncologic disease and to compare this with values published in the literature
Secondary Objectives - The secondary objectives of the clinical trial are to confirm the general utility and value of 18F-FDG imaging of abnormal glucose metabolism in oncologic applications particularly with respect to Canadian practice
Study Design
The proposed clinical trial will be a combined Phase III Phase III extended Phase III Phase IIIIIIexIII diagnostic imaging controlled open label single site clinical trial in a broad cross-section of CCI patients including patients with Hodgkin and non-Hodgkin lymphoma colorectal cancer breast cancer melanoma head and neck cancers PRUNK esophageal cancer thyroid cancer NSCLC SCLC neuroendocrine tumours and patients with CNS tumours where conventional imaging methods have failed to yield a diagnostic answer
Each patient will usually receive a single IV injection of 18F-FDG Imaging will be conducted 30 to 60 minutes after an average injection of 200 - 300 MBq of 18F-FDG in hydrated fasted patients Images will be collected for 40 to 60 minutes in 5 - 7 body positions total counts 5 to 15 million For the Phase III study images will be interpreted by a single experienced Nuclear Medicine physician with regard to normal physiological uptake of 18F-FDG For the Phase III study images will be interpreted independently by two experienced Nuclear Medicine physicians with regard to normal physiological uptake of 18F-FDG The location and intensity of abnormal 18F-FDG uptake will be noted and correlated with clinical findings surgical or biopsy results or with conventional imaging techniques as available The image review will be supplemented with access to clinical and conventional imaging data in the Phase III study In the Phase III study all images will be reviewed independently by one physician blinded to all clinical data except the primary diagnosis and by one physician with access to all relevant clinical information In the extended Phase III protocol the images will be interpreted by a single physician with access to relevant clinical information
Statistical Analyses
Sample Size
The Phase III stage will enroll 20 subjects without regard for tumour type The Phase III stage will enroll approximately 300 subjects and the extended Phase III stage will enroll approximately 3000 subjects with the approximate distribution by tumour type as follows
Tumour Type Phase IIIExtended Phase III
Brain 10100
Colorectal 33330
Breast 21210
Lung NSCLC SCLC 1301300
Lymphoma Hodgkins and non-Hodgkins 22220
Head Neck 16160
Neuroendocrine 10100
Thyroid 29290
Melanoma 15150
PRUNK 14140
Within each cancer subgroup in the Phase III stage where disease status confirmation is available the sensitivity true positive outcomestrue positive outcomes false negative outcomes and positive predictive value true positive outcomestrue positive outcomes false positive outcomes will be calculated on a per patient basis The general criteria for assessment of comparability is that the study group sensitivity percent and positive predictive value percent values have a difference of not less than 15 percent from the appropriately matched literature values For subgroups with significant patient numbers statistical analysis of comparability will be undertaken
Criteria for Evaluability of Study Subject Data All subjects enrolled in the Phase III stage of the trial will be evaluated for safety All subjects enrolled in the Phase III and extended Phase III study will be evaluated for safety and efficacy
Study Population
Number of Subjects to be Studied Phase III stage 20 Phase III stage 300 Extended Phase III stage 3000 Some variation in the patient numbers studied is anticipated in the Phase III and extended Phase III depending on local conditions and timing
Inclusion Criteria for Selection of Study Subjects
Patients will be included in the study if they meet all of the following general criteria
1 Male or female
2 Known or suspected primary or metastatic tumours
3 Age greater than or equal to 15
4 If female of child-bearing potential a reliable method of contraception must be combined with a negative pregnancy test before entering the study contraception must be used for 1 month after the last administration of 18F-FDG If male a barrier method of contraception should be used for up to 1 month after the last administration of 18F-FDG
5 Able and willing to follow instructions and comply with the protocol
6 Provide written informed consent prior to participation in the study
7 Karnofsky Performance Scale Score 60-100
Exclusion Criteria
Patients will be excluded from the study if they meet any of the following criteria
1 significant renal impairment serum creatinine 200 µmolL
2 Coagulopathy prothrombin time PT or activated partial thromboplastin time APTT 15 times control
3 Significant Thrombocytopenia platelet count 75000mm3
4 Granulocytopenia absolute neutrophil count 1000mm3
5 Blood glucose level Significant liver function impairment total bilirubin 20 mgdL AST or ALT 3 times the upper limit of normal or greater than 10
6 Presence of a severe infection
7 Having had surgery or radiotherapy within 10 days of the planned imaging study
8 Nursing or pregnant females
9 Age less than 15
Positron Emission Tomography PET is a specialised Nuclear Medicine procedure that uses positron emitting radiolabeled tracer molecules to measure biological activity The commonest of these radiolabeled tracers is 18F-Fluorodeoxyglucose 18F-FDG which is used to determine abnormal glucose metabolism in tumours and other sites It has general applications in all areas where abnormal glucose metabolism may be present including circumstances such as differentiating tumour from scar tissue evaluating the presence of tumour in the light of rising tumour markers and normal morphological imaging techniques and assessing response to therapy where other techniques are deemed to be unhelpful
The Cross Cancer Institute has recently been funded to establish a PET centre that will establish a research programme to prove the effectiveness of PET scanning in the Canadian health care environment and validate the data that have been developed in other jurisdictions in specific oncologic indications
Objectives
Primary Objectives - The objectives of the clinical trial are to a demonstrate the safety of 18F-FDG synthesised from cyclotron produced radiofluoride in the Coincidence Technologies automated synthesis unit ASU in the Edmonton PET Centre facility and b confirm the diagnostic effectiveness of 18F-FDG in subjects with known or suspected oncologic disease and to compare this with values published in the literature
Secondary Objectives - The secondary objectives of the clinical trial are to confirm the general utility and value of 18F-FDG imaging of abnormal glucose metabolism in oncologic applications particularly with respect to Canadian practice
Study Design
The proposed clinical trial will be a combined Phase III Phase III extended Phase III Phase IIIIIIexIII diagnostic imaging controlled open label single site clinical trial in a broad cross-section of CCI patients including patients with Hodgkin and non-Hodgkin lymphoma colorectal cancer breast cancer melanoma head and neck cancers PRUNK esophageal cancer thyroid cancer NSCLC SCLC neuroendocrine tumours and patients with CNS tumours where conventional imaging methods have failed to yield a diagnostic answer
Each patient will usually receive a single IV injection of 18F-FDG Imaging will be conducted 30 to 60 minutes after an average injection of 200 - 300 MBq of 18F-FDG in hydrated fasted patients Images will be collected for 40 to 60 minutes in 5 - 7 body positions total counts 5 to 15 million For the Phase III study images will be interpreted by a single experienced Nuclear Medicine physician with regard to normal physiological uptake of 18F-FDG For the Phase III study images will be interpreted independently by two experienced Nuclear Medicine physicians with regard to normal physiological uptake of 18F-FDG The location and intensity of abnormal 18F-FDG uptake will be noted and correlated with clinical findings surgical or biopsy results or with conventional imaging techniques as available The image review will be supplemented with access to clinical and conventional imaging data in the Phase III study In the Phase III study all images will be reviewed independently by one physician blinded to all clinical data except the primary diagnosis and by one physician with access to all relevant clinical information In the extended Phase III protocol the images will be interpreted by a single physician with access to relevant clinical information
Statistical Analyses
Sample Size
The Phase III stage will enroll 20 subjects without regard for tumour type The Phase III stage will enroll approximately 300 subjects and the extended Phase III stage will enroll approximately 3000 subjects with the approximate distribution by tumour type as follows
Tumour Type Phase IIIExtended Phase III
Brain 10100
Colorectal 33330
Breast 21210
Lung NSCLC SCLC 1301300
Lymphoma Hodgkins and non-Hodgkins 22220
Head Neck 16160
Neuroendocrine 10100
Thyroid 29290
Melanoma 15150
PRUNK 14140
Within each cancer subgroup in the Phase III stage where disease status confirmation is available the sensitivity true positive outcomestrue positive outcomes false negative outcomes and positive predictive value true positive outcomestrue positive outcomes false positive outcomes will be calculated on a per patient basis The general criteria for assessment of comparability is that the study group sensitivity percent and positive predictive value percent values have a difference of not less than 15 percent from the appropriately matched literature values For subgroups with significant patient numbers statistical analysis of comparability will be undertaken
Criteria for Evaluability of Study Subject Data All subjects enrolled in the Phase III stage of the trial will be evaluated for safety All subjects enrolled in the Phase III and extended Phase III study will be evaluated for safety and efficacy
Study Population
Number of Subjects to be Studied Phase III stage 20 Phase III stage 300 Extended Phase III stage 3000 Some variation in the patient numbers studied is anticipated in the Phase III and extended Phase III depending on local conditions and timing
Inclusion Criteria for Selection of Study Subjects
Patients will be included in the study if they meet all of the following general criteria
1 Male or female
2 Known or suspected primary or metastatic tumours
3 Age greater than or equal to 15
4 If female of child-bearing potential a reliable method of contraception must be combined with a negative pregnancy test before entering the study contraception must be used for 1 month after the last administration of 18F-FDG If male a barrier method of contraception should be used for up to 1 month after the last administration of 18F-FDG
5 Able and willing to follow instructions and comply with the protocol
6 Provide written informed consent prior to participation in the study
7 Karnofsky Performance Scale Score 60-100
Exclusion Criteria
Patients will be excluded from the study if they meet any of the following criteria
1 significant renal impairment serum creatinine 200 µmolL
2 Coagulopathy prothrombin time PT or activated partial thromboplastin time APTT 15 times control
3 Significant Thrombocytopenia platelet count 75000mm3
4 Granulocytopenia absolute neutrophil count 1000mm3
5 Blood glucose level Significant liver function impairment total bilirubin 20 mgdL AST or ALT 3 times the upper limit of normal or greater than 10
6 Presence of a severe infection
7 Having had surgery or radiotherapy within 10 days of the planned imaging study
8 Nursing or pregnant females
9 Age less than 15
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None