Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123773
Status:
COMPLETED
Last Update Posted:
2016-02-26
First Post:
2005-07-22
Brief Title:
Study of F-Fluorodeoxyglucose FluGlucoScan in Patients With Known or Suspected Cancers of Low Incidence
Sponsor:
AHS Cancer Control Alberta
Organization:
AHS Cancer Control Alberta
Study Overview
Official Title:
A Phase II Study of F-Fluorodeoxyglucose FluGlucoScan in Patients With Known or Suspected Cancers of Low Incidence
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 has recently been funded to establish a PET centre and this study will evaluate the effectiveness value and safety of PET scanning in a number of uncommon cancers in the Canadian health care environment
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 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 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 Objective - The objective of the clinical trial is to establish the general utility and value of 18F-FDG PET imaging in patients with known or suspected myeloma sarcoma testicular cancer seminomatous and non-seminomatous germ cell tumors endometrial cancer ovarian cancer cervical cancer transitional cell carcinoma of the bladder renal cell carcinoma pancreatic adenocarcinoma mesothelioma and gastric cancer
Secondary Objectives - The secondary objective of the clinical trial is to demonstrate the safety by documentation of adverse events
Study Design
The proposed clinical trial will be a Phase II diagnostic imaging open label single site clinical trial in patients with defined oncologic disease The patient population will consist of patients with suspected or known infrequently occurring cancers which are not covered by Protocol DX-FDG-001 This population includes patients with known or suspected myeloma sarcoma testicular cancer seminomatous and non-seminomatous germ cell tumors endometrial cancer ovarian cancer cervical cancer transitional cell carcinoma of the bladder renal cell carcinoma pancreatic adenocarcinoma mesothelioma and gastric cancer
Each patient will receive a single IV injection of 18F-FDG Imaging will be conducted 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 using either the C-PET Allegro or Gemini PET scanners located in Nuclear Medicine Standard transaxial images will be reconstructed from the collected data and can be re-oriented into coronal or sagittal slices as required The images will then be examined by an experienced nuclear medicine physician 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 and conventional imaging techniques as available
Statistical Analyses
Sample Size
The study will enrol approximately 220 subjects with an approximate maximum of 20 subjects per specific tumour type myeloma sarcoma testicular cancer seminomatous and non-seminomatous germ cell tumors endometrial cancer ovarian cancer cervical cancer transitional cell carcinoma of the bladder renal cell carcinoma pancreatic adenocarcinoma mesothelioma and gastric cancer
Statistical Analyses
For each group the investigators will calculate the positive predictive value true positive outcomestrue positive outcomes false positive outcomes of the 18F-FDG scan They also intend to evaluate the percentage of patients in which the 18F-FDG outcome affected patient management
Criteria for Evaluability of Study Subject Data
All subjects receiving 18F -FDG will be evaluated for safety and efficacy
Study Population
Number of Subjects to be Studied
Approximately 220 patients overall approximately 20 in each cancer type
Inclusion Criteria for Selection of Study Subjects
Patients will be included in the study if they meet all of the following criteria
1 Male or female If female of child-bearing potential and outside of the window of 10 days since the last menstrual period a negative serum pregnancy test
2 Known or suspected primary or metastatic tumours of myeloma sarcoma testicular cancer seminomatous and non-seminomatous germ cell tumors endometrial cancer ovarian cancer cervical cancer transitional cell carcinoma of the bladder renal cell carcinoma pancreatic adenocarcinoma mesothelioma and gastric cancer
3 Age greater than or equal to 15 years
4 Able and willing to follow instructions and comply with the protocol
5 Provide written informed consent prior to participation in this 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 Having had surgery or radiotherapy within 10 days of the planned imaging study
2 Nursing or pregnant females
3 Age less than 15 years
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 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 Objective - The objective of the clinical trial is to establish the general utility and value of 18F-FDG PET imaging in patients with known or suspected myeloma sarcoma testicular cancer seminomatous and non-seminomatous germ cell tumors endometrial cancer ovarian cancer cervical cancer transitional cell carcinoma of the bladder renal cell carcinoma pancreatic adenocarcinoma mesothelioma and gastric cancer
Secondary Objectives - The secondary objective of the clinical trial is to demonstrate the safety by documentation of adverse events
Study Design
The proposed clinical trial will be a Phase II diagnostic imaging open label single site clinical trial in patients with defined oncologic disease The patient population will consist of patients with suspected or known infrequently occurring cancers which are not covered by Protocol DX-FDG-001 This population includes patients with known or suspected myeloma sarcoma testicular cancer seminomatous and non-seminomatous germ cell tumors endometrial cancer ovarian cancer cervical cancer transitional cell carcinoma of the bladder renal cell carcinoma pancreatic adenocarcinoma mesothelioma and gastric cancer
Each patient will receive a single IV injection of 18F-FDG Imaging will be conducted 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 using either the C-PET Allegro or Gemini PET scanners located in Nuclear Medicine Standard transaxial images will be reconstructed from the collected data and can be re-oriented into coronal or sagittal slices as required The images will then be examined by an experienced nuclear medicine physician 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 and conventional imaging techniques as available
Statistical Analyses
Sample Size
The study will enrol approximately 220 subjects with an approximate maximum of 20 subjects per specific tumour type myeloma sarcoma testicular cancer seminomatous and non-seminomatous germ cell tumors endometrial cancer ovarian cancer cervical cancer transitional cell carcinoma of the bladder renal cell carcinoma pancreatic adenocarcinoma mesothelioma and gastric cancer
Statistical Analyses
For each group the investigators will calculate the positive predictive value true positive outcomestrue positive outcomes false positive outcomes of the 18F-FDG scan They also intend to evaluate the percentage of patients in which the 18F-FDG outcome affected patient management
Criteria for Evaluability of Study Subject Data
All subjects receiving 18F -FDG will be evaluated for safety and efficacy
Study Population
Number of Subjects to be Studied
Approximately 220 patients overall approximately 20 in each cancer type
Inclusion Criteria for Selection of Study Subjects
Patients will be included in the study if they meet all of the following criteria
1 Male or female If female of child-bearing potential and outside of the window of 10 days since the last menstrual period a negative serum pregnancy test
2 Known or suspected primary or metastatic tumours of myeloma sarcoma testicular cancer seminomatous and non-seminomatous germ cell tumors endometrial cancer ovarian cancer cervical cancer transitional cell carcinoma of the bladder renal cell carcinoma pancreatic adenocarcinoma mesothelioma and gastric cancer
3 Age greater than or equal to 15 years
4 Able and willing to follow instructions and comply with the protocol
5 Provide written informed consent prior to participation in this 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 Having had surgery or radiotherapy within 10 days of the planned imaging study
2 Nursing or pregnant females
3 Age less than 15 years
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