Ignite Creation Date:
2024-05-06 @ 5:41 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05396118
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-14
First Post:
2022-05-12
Brief Title:
Simultaneous Hyperpolarized 1-13CPyruvate and 18F-FDG PETMRS in Cancer Patients
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Phase IIa Clinical Trial Feasibility Study on Non-Invasive Simultaneous Hyperpolarized 1-13CPyruvate Magnetic Resonance Spectroscopy and 18F-FDG PET hyperPET for Metabolic Imaging in Patients With Cancer
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
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:
Prospective phase 2a clinical trial to demonstrate proof-of-concept for simultaneous hyperpolarized 1-13Cpyruvate and 18F-FDG for positron emission tomography PET and MRS magnetic resonance spectroscopy in a PETMR scanner in patients with cancer
Detailed Description:
PET imaging with 18F-FDG is a well established method for non invasively assessing the intracellular glucose accumulation 18F-FDG PET is used in many applications with diagnosing and staging of patients with cancer being one of the primary indications Once internalized into the cell 18F-FDG is phosphorylated to the metabolically inactive 18F-FDG-6-phosphate Therefore it is not possible to determine what happens to the downstream glucose metabolites In particular it is not possible to determine the conversion into lactate which is upregulated in many cancers The upregulation of lactate conversion in cancers even in presence of oxygen is known as the Warburg effect
Hyperpolarized 1-13Cpyruvate MRS makes is possible to circumvent this limitation The technique makes is it possible to follow the downstream fate of the glycolysis intermediate pyruvate and in particular makes is is possible to non-invasively and in in real time measure the glycolytic conversion of pyruvate into lactate as a direct measure of the Warburg effect
When using a PETMR scanner it is possible to simultaneous measure the glucose influx with 18F-FDG and the conversion of pyruvate into lactate with hyperpolarized 1-13Cpyruvate In this way the two modalities provide complementary information on the in vivo glycose metabolism
The prospective phase 2a project will include up to 15 patients diagnosed with breast cancer gastro-entero-pancreatic neuroendocrine neoplasms GEP-NEN of all grades G1 G2 G3 lymphomas or sarcomas The aim is to demonstrate proof-of-concept for the feasibility of simultaneous acquisition of hyperpolarized 1-13Cpyruvate MRS and 18F-FDG PET imaging in a PETMR scanner in cancer patients to allow for simultaneous measurements of overall tumor pyruvate-to-lactate conversion parameters on MRS and glucose influx with 18F-FDG on PET
Included patients are injected with a standard dose of radioactive 18F-FDG Subsequent dynamic PET acquisition is performed for up to 90 minutes after injection on an area-of-interest covering pre-specified tumor lesions Regional anatomical magnetic resonance imaging MRI is performed including diffusion weighted imaging DWI and contrast enhanced imaging DCE MRSMRSI is performed following the injections of hyperpolarized 1-13CPyruvate
When available resected tumor tissues samples from surgical specimens or biopsies obtained in relation to routine clinical procedures will be collected and analyses of enzymes and markers of glycolytic metabolism will be performed ex vivo and compared with the in vivo data from PETMRS
Hyperpolarized 1-13Cpyruvate MRS makes is possible to circumvent this limitation The technique makes is it possible to follow the downstream fate of the glycolysis intermediate pyruvate and in particular makes is is possible to non-invasively and in in real time measure the glycolytic conversion of pyruvate into lactate as a direct measure of the Warburg effect
When using a PETMR scanner it is possible to simultaneous measure the glucose influx with 18F-FDG and the conversion of pyruvate into lactate with hyperpolarized 1-13Cpyruvate In this way the two modalities provide complementary information on the in vivo glycose metabolism
The prospective phase 2a project will include up to 15 patients diagnosed with breast cancer gastro-entero-pancreatic neuroendocrine neoplasms GEP-NEN of all grades G1 G2 G3 lymphomas or sarcomas The aim is to demonstrate proof-of-concept for the feasibility of simultaneous acquisition of hyperpolarized 1-13Cpyruvate MRS and 18F-FDG PET imaging in a PETMR scanner in cancer patients to allow for simultaneous measurements of overall tumor pyruvate-to-lactate conversion parameters on MRS and glucose influx with 18F-FDG on PET
Included patients are injected with a standard dose of radioactive 18F-FDG Subsequent dynamic PET acquisition is performed for up to 90 minutes after injection on an area-of-interest covering pre-specified tumor lesions Regional anatomical magnetic resonance imaging MRI is performed including diffusion weighted imaging DWI and contrast enhanced imaging DCE MRSMRSI is performed following the injections of hyperpolarized 1-13CPyruvate
When available resected tumor tissues samples from surgical specimens or biopsies obtained in relation to routine clinical procedures will be collected and analyses of enzymes and markers of glycolytic metabolism will be performed ex vivo and compared with the in vivo data from PETMRS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None