Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123786
Status:
TERMINATED
Last Update Posted:
2016-02-25
First Post:
2005-07-22
Brief Title:
Study of 18F-Fluorodeoxyglucose FluGlucoScan in Patients With Known or Suspected Soft Tissue Sarcoma
Sponsor:
AHS Cancer Control Alberta
Organization:
AHS Cancer Control Alberta
Study Overview
Official Title:
A Phase II Study of 18F-Fluorodeoxyglucose FluGlucoScan in Patients With Known or Suspected Soft Tissue Sarcoma
Status:
TERMINATED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of Enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
18F-fluorodeoxyglucose 18F-FDG has been approved by many regulatory agencies world-wide and is in widespread use in the United States Japan and Europe In the United States 18F-FDG scanning in oncology is approved for federal healthcare reimbursement for non-Hodgkins lymphoma Hodgkins disease colorectal cancer lung cancer oesophageal cancer melanoma head and neck cancer and breast cancer 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 imaging techniques and assessing response to therapy where other techniques are deemed to be unhelpful Current literature suggests that functional imaging with 18F-FDG Positron Emission Tomography PET may play an important role in the imaging evaluation of patients with soft tissue sarcoma including guiding biopsy detecting local recurrence at sites of tumour resection detecting metastatic disease predicting and monitoring response to therapy and assessing for prognosis In appropriate situations it is possibly the most effective diagnostic strategy However due to the low incidence of these tumours prospective studies with large multicenter patient groups will be essential to define the exact diagnostic role of 18F-FDG PET in this clinical setting
Detailed Description:
Background Positron Emission Tomography PET is a specialized nuclear medicine procedure that uses positron emitting radiolabeled tracer molecules to measure biological activity The most common of these tracers 18F-2-fluoro-2-deoxyglucose FGD an analog of glucose is used to determine abnormal glucose metabolism in tumours and other sites FDG has general applications where abnormal glucose metabolism may be present such as differentiating tumour from scar tissue evaluating the presence of tumour in light of rising tumour markers and normal morphological imaging and assessing response to therapy
The Cross Cancer Institute has been funded to establish a PET centre and research program 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 A cyclotron has been installed at the Cross Cancer Institute which produces 18F-fluoride that is used in the automated synthesis of FDG The three PET scanners in the Department of Oncologic Imaging will be used for this protocol
Objectives
Primary - establish the general utility and value of FDG-PET imaging in patients with known or suspected soft tissue sarcoma
Secondary - demonstrate the safety of FDG-PET imaging by documentation of adverse events determine whether the number of subjects available for study at the Cross Cancer Institute is sufficient to achieve statistically significant results determine the feasibility of extending this study to a larger multicenter design
Study Design The proposed trial will be a Phase II diagnostic imaging open label single site clinical trial The patient population will consist of patients with known or suspected soft tissue sarcoma This will also be a pilot study to test the feasibility of extending this trial to a larger multicenter design in view of increasing sample size and strengthening conclusions about safety and effectiveness of FDG-PET imaging in this population
With each scan the patient will receive a single IV injection of FDG Initial imaging will be conducted 60 minutes after an average injection of 200-300 MBq of FDG dose is dependent on which scanner is used and patients weight The images will then be examined by an experienced nuclear medicine physician and the location and intensity of abnormal FDG uptake will be reported The referring physician will then correlate the findings with the results of clinical examinations and conventional imaging
Statistical Analysis The investigators will calculate the positive predictive value PPV of the FDG scans They also intend to evaluate the percentage of patients in which the FDG scan outcome affected patient management
Stopping Rules The subject is free to withdraw at any time The investigator also has the right to withdraw a subject from the study in the event of intercurrent illness or other reasons concerning the health or well being of the subject or in case of lack of cooperation Should a subject decide to withdraw or the investigator decide to withdraw the subject after administration of FDG all efforts will be made to complete and report follow-up observations as thoroughly as possible providing consent is still valid A complete final evaluation at the time of the subjects withdrawal is to be made with an explanation of why the subject is withdrawing or being withdrawn from the study If the reason for withdrawing a subject from the study is a specific event or an abnormal laboratory test result the event or test result must be recorded as an adverse event and entered into the Case Report Form
Data Safety Monitoring Committee Preliminary data will be analyzed for safety and effectiveness on a yearly basis until the study ends
The Cross Cancer Institute has been funded to establish a PET centre and research program 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 A cyclotron has been installed at the Cross Cancer Institute which produces 18F-fluoride that is used in the automated synthesis of FDG The three PET scanners in the Department of Oncologic Imaging will be used for this protocol
Objectives
Primary - establish the general utility and value of FDG-PET imaging in patients with known or suspected soft tissue sarcoma
Secondary - demonstrate the safety of FDG-PET imaging by documentation of adverse events determine whether the number of subjects available for study at the Cross Cancer Institute is sufficient to achieve statistically significant results determine the feasibility of extending this study to a larger multicenter design
Study Design The proposed trial will be a Phase II diagnostic imaging open label single site clinical trial The patient population will consist of patients with known or suspected soft tissue sarcoma This will also be a pilot study to test the feasibility of extending this trial to a larger multicenter design in view of increasing sample size and strengthening conclusions about safety and effectiveness of FDG-PET imaging in this population
With each scan the patient will receive a single IV injection of FDG Initial imaging will be conducted 60 minutes after an average injection of 200-300 MBq of FDG dose is dependent on which scanner is used and patients weight The images will then be examined by an experienced nuclear medicine physician and the location and intensity of abnormal FDG uptake will be reported The referring physician will then correlate the findings with the results of clinical examinations and conventional imaging
Statistical Analysis The investigators will calculate the positive predictive value PPV of the FDG scans They also intend to evaluate the percentage of patients in which the FDG scan outcome affected patient management
Stopping Rules The subject is free to withdraw at any time The investigator also has the right to withdraw a subject from the study in the event of intercurrent illness or other reasons concerning the health or well being of the subject or in case of lack of cooperation Should a subject decide to withdraw or the investigator decide to withdraw the subject after administration of FDG all efforts will be made to complete and report follow-up observations as thoroughly as possible providing consent is still valid A complete final evaluation at the time of the subjects withdrawal is to be made with an explanation of why the subject is withdrawing or being withdrawn from the study If the reason for withdrawing a subject from the study is a specific event or an abnormal laboratory test result the event or test result must be recorded as an adverse event and entered into the Case Report Form
Data Safety Monitoring Committee Preliminary data will be analyzed for safety and effectiveness on a yearly basis until the study ends
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