Ignite Creation Date:
2024-05-06 @ 2:32 PM
Last Modification Date:
2024-10-26 @ 1:32 PM
Study NCT ID:
NCT04349410
Status:
COMPLETED
Last Update Posted:
2020-11-12
First Post:
2020-04-11
Brief Title:
The Fleming FMTVDM Directed CoVid-19 Treatment Protocol
Sponsor:
The Camelot Foundation
Organization:
The Camelot Foundation
Study Overview
Official Title:
The Fleming FMTVDM Directed CoVid-19 Treatment Protocol
Status:
COMPLETED
Status Verified Date:
2020-10
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:
FMTVDM
Brief Summary:
Diagnostic determination of disease and treatment responses has been limited to qualitative imaging measurement of serum markers of disease and sampling of tissue In each of these instances there is a built in error either due to sensitivity and specificity issues clinician interpretation of results or acceptance of the use of an indirect marker blood test of what is happening elsewhere in the body - at the tissue level
The Fleming Method for Tissue and Vascular Differentiation and Metabolism FMTVDM using same state single or sequential quantification comparisons 1 provides the first and only patented test 9566037 - along with the associated submitted patent applications ruled to be covered under 9566037 - that quantitatively measures changes in tissue resulting from inter alia a disease process This includes inter alia coronary artery disease CAD cancer and infectiousinflammatory processes including CoVid-19 pneumonia CVP resulting from the metabolic and regional blood flow differences RBFDs caused by these diseases
The purpose of this paper is to make clinicians and researchers aware of this proposed method for investigating the prevalence and severity of CVP - in addition to providing rapid determination of treatment response in each patient directing treatment decisions thereby reducing the loss of time money resources and patient lives
The Fleming Method for Tissue and Vascular Differentiation and Metabolism FMTVDM using same state single or sequential quantification comparisons 1 provides the first and only patented test 9566037 - along with the associated submitted patent applications ruled to be covered under 9566037 - that quantitatively measures changes in tissue resulting from inter alia a disease process This includes inter alia coronary artery disease CAD cancer and infectiousinflammatory processes including CoVid-19 pneumonia CVP resulting from the metabolic and regional blood flow differences RBFDs caused by these diseases
The purpose of this paper is to make clinicians and researchers aware of this proposed method for investigating the prevalence and severity of CVP - in addition to providing rapid determination of treatment response in each patient directing treatment decisions thereby reducing the loss of time money resources and patient lives
Detailed Description:
FMTVDM - See Appendix A
1 Quantitatively calibrates the nuclear camera to guarantee that the measurements made by the camera are accurate consistent and reproducible This quantification is dependent upon the isotope being used the camera and the timing sequence of image acquisition Such calibration is NOT currently done and it is part of the patent Studies have demonstrated that the lack of this quantitative calibration has resulted in up to 13 of the data being lost for SUV and qualitative interpretation in addition to making quantification impossible
2 The patient presents in a fasting state - to eliminate digestive processes from interfering with blood flow distributions - and the differences in metabolic and regional blood flow differences RBFDs are enhanced with vasodilatory agents shifting blood flow and isotope towards regions of greater blood flow and metabolism enhancing isotope delivery uptake and quantification
3 With a now quantitatively calibrated nuclear camera - in this instance a PLANAR camera - or SPECTCT or PETCTMRI if specifically approved - to allow imaging to be done at patients bedside reducing the use of hospital resources required for transport and decrease potential for patient complications resulting from a transport - image acquisition will occur for 10-minutes following peak enhancement effect of the vasodilatory agent and timed injection of the isotope based upon the enhancing agent
Regions-of-interest ROIs will drawn by the nuclear technologist - either at the bedside or in the nuclear laboratory - to provide FMTVDM measurements using software already present in the nuclear camera systems Specific ROIs will be drawn of the right lung total left lung total mediastinum thymus activity and any specific areas where increased tracer uptake is noted
4 These FMTVDM measurements including MAXIMAL COUNTS - VARIANCE provide the values of the most active pulmonary tissue resulting from the CoVid-19 infection and inflammatory response just as it has previously been used for CAD and Cancer
5 From these FMTVDM measurements the pulmonary tissue and the CoVid-19 infectious process results are placed on a Health-Spectrum showing where in the tissue transitioning process the patient is The measurements also provide information about how rapidly the tissue is changing FMTVDM provides the quantitative measurement of where the patient is at any point in time during their course of treatment and how they compare with other patients
6 Once the FMTVDM measurements have been obtained treatment decisions can be made based upon serial changes in FMTVDM Treatments outcomes are based upon FMTVDM measurements including the maximum FMTVDM and the variance in those measurements By comparing serial FMTVDM results improvement or deterioration in the patients health and the success or failure of the current treatment regimen is measured providing patient-centered patient-specific patient-oriented and patient-directed decisions Thus saving time money resources and lives - not to mention unnecessary side effects from treatment which is not working
1 Quantitatively calibrates the nuclear camera to guarantee that the measurements made by the camera are accurate consistent and reproducible This quantification is dependent upon the isotope being used the camera and the timing sequence of image acquisition Such calibration is NOT currently done and it is part of the patent Studies have demonstrated that the lack of this quantitative calibration has resulted in up to 13 of the data being lost for SUV and qualitative interpretation in addition to making quantification impossible
2 The patient presents in a fasting state - to eliminate digestive processes from interfering with blood flow distributions - and the differences in metabolic and regional blood flow differences RBFDs are enhanced with vasodilatory agents shifting blood flow and isotope towards regions of greater blood flow and metabolism enhancing isotope delivery uptake and quantification
3 With a now quantitatively calibrated nuclear camera - in this instance a PLANAR camera - or SPECTCT or PETCTMRI if specifically approved - to allow imaging to be done at patients bedside reducing the use of hospital resources required for transport and decrease potential for patient complications resulting from a transport - image acquisition will occur for 10-minutes following peak enhancement effect of the vasodilatory agent and timed injection of the isotope based upon the enhancing agent
Regions-of-interest ROIs will drawn by the nuclear technologist - either at the bedside or in the nuclear laboratory - to provide FMTVDM measurements using software already present in the nuclear camera systems Specific ROIs will be drawn of the right lung total left lung total mediastinum thymus activity and any specific areas where increased tracer uptake is noted
4 These FMTVDM measurements including MAXIMAL COUNTS - VARIANCE provide the values of the most active pulmonary tissue resulting from the CoVid-19 infection and inflammatory response just as it has previously been used for CAD and Cancer
5 From these FMTVDM measurements the pulmonary tissue and the CoVid-19 infectious process results are placed on a Health-Spectrum showing where in the tissue transitioning process the patient is The measurements also provide information about how rapidly the tissue is changing FMTVDM provides the quantitative measurement of where the patient is at any point in time during their course of treatment and how they compare with other patients
6 Once the FMTVDM measurements have been obtained treatment decisions can be made based upon serial changes in FMTVDM Treatments outcomes are based upon FMTVDM measurements including the maximum FMTVDM and the variance in those measurements By comparing serial FMTVDM results improvement or deterioration in the patients health and the success or failure of the current treatment regimen is measured providing patient-centered patient-specific patient-oriented and patient-directed decisions Thus saving time money resources and lives - not to mention unnecessary side effects from treatment which is not working
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None