Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544187
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Can Imaging be an Alternative to Exercise Testing as a Predictor of Surgical Fitness
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Can Imaging be an Alternative to Exercise Testing as a Predictor of Surgical Fitness
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESPIRE
Brief Summary:
This study aims to explore an alternative method for assessing a participants readiness for surgery specifically for those undergoing surgery for gastric oesophageal or pancreatic cancer Surgery for these diseases is extremely demanding on the body and surgeons need to be confident that a patient can tolerate the procedure
Traditionally participants undergo Cardiopulmonary Exercise Tests CPET to determine their fitness for surgery This involves cycling on an exercise bike with increasing resistance until the resistance is too great to continue cycling at a constant rate An individuals maximum rate of oxygen consumption VO2max and the anaerobic threshold AT are calculated during CPET and used by surgeons as a predictor for surgical fitness CPET tests can be physically demanding for participants and are very resource intensive Furthermore some patients may not be able to tolerate exercise tests due to physical constraints
An alternative method Magnetic Resonance Spectroscopy MRS could be used to measure an individuals fitness prior to surgery Within this study MRS will be used to determine the levels of fat within the thigh muscle which in turn may be able to be used to predict fitness for surgery
The first phase includes recruiting participants on the surgical pathway MRS will be performed as an additional examination typically on the same day as the CPET Fat levels determined from MRS will be compared with conventional CPET outcomes VO2max and AT This analysis aims to determine if MRS derived fat levels correlates with VO2max and AT and if correlation is high potentially providing an alternative to CPET for patients who cannot tolerate exercise tests
The second phase involves recruiting volunteers who will undergo repeated MRS scans to assess the reliability of MRS methods This process allows us to understand the consistency of MRS derived fat levels over both short and long-term intervals
The potential benefits of this project include an additional pathway for assessing fitness for surgery or enhancing the presurgical pathway for patients by providing an alternative method for fitness assessment This study aims to provide evidence that could present an alternative method of assessing a patients fitness for surgery The goal is to explore an alternative that may complement or refine current practices in preoperative assessments
Traditionally participants undergo Cardiopulmonary Exercise Tests CPET to determine their fitness for surgery This involves cycling on an exercise bike with increasing resistance until the resistance is too great to continue cycling at a constant rate An individuals maximum rate of oxygen consumption VO2max and the anaerobic threshold AT are calculated during CPET and used by surgeons as a predictor for surgical fitness CPET tests can be physically demanding for participants and are very resource intensive Furthermore some patients may not be able to tolerate exercise tests due to physical constraints
An alternative method Magnetic Resonance Spectroscopy MRS could be used to measure an individuals fitness prior to surgery Within this study MRS will be used to determine the levels of fat within the thigh muscle which in turn may be able to be used to predict fitness for surgery
The first phase includes recruiting participants on the surgical pathway MRS will be performed as an additional examination typically on the same day as the CPET Fat levels determined from MRS will be compared with conventional CPET outcomes VO2max and AT This analysis aims to determine if MRS derived fat levels correlates with VO2max and AT and if correlation is high potentially providing an alternative to CPET for patients who cannot tolerate exercise tests
The second phase involves recruiting volunteers who will undergo repeated MRS scans to assess the reliability of MRS methods This process allows us to understand the consistency of MRS derived fat levels over both short and long-term intervals
The potential benefits of this project include an additional pathway for assessing fitness for surgery or enhancing the presurgical pathway for patients by providing an alternative method for fitness assessment This study aims to provide evidence that could present an alternative method of assessing a patients fitness for surgery The goal is to explore an alternative that may complement or refine current practices in preoperative assessments
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