Ignite Creation Date:
2024-05-06 @ 2:25 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02038348
Status:
COMPLETED
Last Update Posted:
2022-11-14
First Post:
2013-12-03
Brief Title:
Interest of the 18F-DOPA-PET Imaging in Metastatic Melanoma Treated With B-RAF Inhibitors a Pilot Study
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Interest of the 18F-DOPA-PET Imaging in Metastatic Melanoma Treated With B-RAF Inhibitors a Pilot Study
Status:
COMPLETED
Status Verified Date:
2022-11
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:
Melanoma incidence is increasing in most developed countries At the metastatic stage the prognosis is usually poor Major advances have been obtained over the last 3 years with the development of therapies targeting the MAP kinases pathway
Vemurafenib zelboraf is approved in France since 2012 as first treatment of metastatic melanoma carrying a B-RAF mutation
For growth the tumor needs an adequate supply of nutrients to allow the synthesis of macromolecules and a contribution in carbon elements to ensure the production of energy The nutrition demand is met through greater availability of nutrients via tumor angiogenesis and through increased intracellular penetration of nutrients via specific upregulation of transport systems and metabolic pathways
Scanner is the imaging method most commonly used for the evaluation of therapeutic response Such a method gives a morphological indication but does not evaluate the metabolic response
With the development of functional imaging techniques and the advent of positron emission tomography PET it is now possible to obtain an assessment of the metabolic activity of tumors The use of 18F-FDG to assess therapeutic responses to targeted therapies is fairly recent The advantage of this approach is well documented for GIST and non-small cell lung cancer In melanoma the metabolic response to 18F-FDG is much faster than the response to TAP scanner
18F-FDG tracer that targets glucose metabolism is the most sensitive functional imaging in melanoma which has hindered the development of other tracers such as 18F-FDOPA and 18F-FLT The 18F-FDG TEP can thus be used in the initial staging and follow-up of the disease a situation in which it can replace the TAP scanner additional brain imaging remaining necessary
The use of metabolic imaging to study the response to targeted therapies in melanoma has been the subject of only one publications There was a trend toward improved progression-free survival in patients with high metabolic response at day J15
For melanoma the diagnostic sensitivity of PET 18F-FDOPA is lower than that of 18F-FDG 64 versus 95 In contrast the 18F-FDOPA tracer has the advantage of allowing a brain assessment which is critical in melanoma that gives frequent metastases in the central nervous system There has never been any evaluation of the metabolic response to targeted therapies such as BRAF inhibitors PET with 18F-FDOPA
The investigators propose to conduct a monocentric prospective preliminary study to explore the potential usefulness of the metabolic PET imaging with 18F-FDOPA in the evaluation of metabolic response of B-RAF mutated metastatic melanoma treated with vemurafenib
Vemurafenib zelboraf is approved in France since 2012 as first treatment of metastatic melanoma carrying a B-RAF mutation
For growth the tumor needs an adequate supply of nutrients to allow the synthesis of macromolecules and a contribution in carbon elements to ensure the production of energy The nutrition demand is met through greater availability of nutrients via tumor angiogenesis and through increased intracellular penetration of nutrients via specific upregulation of transport systems and metabolic pathways
Scanner is the imaging method most commonly used for the evaluation of therapeutic response Such a method gives a morphological indication but does not evaluate the metabolic response
With the development of functional imaging techniques and the advent of positron emission tomography PET it is now possible to obtain an assessment of the metabolic activity of tumors The use of 18F-FDG to assess therapeutic responses to targeted therapies is fairly recent The advantage of this approach is well documented for GIST and non-small cell lung cancer In melanoma the metabolic response to 18F-FDG is much faster than the response to TAP scanner
18F-FDG tracer that targets glucose metabolism is the most sensitive functional imaging in melanoma which has hindered the development of other tracers such as 18F-FDOPA and 18F-FLT The 18F-FDG TEP can thus be used in the initial staging and follow-up of the disease a situation in which it can replace the TAP scanner additional brain imaging remaining necessary
The use of metabolic imaging to study the response to targeted therapies in melanoma has been the subject of only one publications There was a trend toward improved progression-free survival in patients with high metabolic response at day J15
For melanoma the diagnostic sensitivity of PET 18F-FDOPA is lower than that of 18F-FDG 64 versus 95 In contrast the 18F-FDOPA tracer has the advantage of allowing a brain assessment which is critical in melanoma that gives frequent metastases in the central nervous system There has never been any evaluation of the metabolic response to targeted therapies such as BRAF inhibitors PET with 18F-FDOPA
The investigators propose to conduct a monocentric prospective preliminary study to explore the potential usefulness of the metabolic PET imaging with 18F-FDOPA in the evaluation of metabolic response of B-RAF mutated metastatic melanoma treated with vemurafenib
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-35 | OTHER | AP HM | None |