Can Imaging be an Alternative to Exercise Testing as a Predictor of Surgical Fitness?
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospitals of North Midlands NHS Trust
About this trial
This study aims to explore an alternative method for assessing a participant's 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 individual's 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 individual's 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 patient's fitness for surgery. The goal is to explore an alternative that may complement or refine current practices in preoperative assessments.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients diagnosed oesophageal/gastric or pancreatic cancer.
Patients who have or a under consideration for a CPET investigation.
Aged ≥ 18.
Existing UHNM Patient.
Disqualifiers
Patients with contraindications to MRI due to safety at 3T.
Patients with metalwork within the imaging field of view (e.g., knee replacement).
Claustrophobic patients.
Patients outside of stated age range to ensure informed consent.
Trial population
Cohort 1: Participants with oesophageal, gastric or pancreatic cancer who are potential candidates for surgical resection (oesophagectomy/gastrectomy/pancreaticoduodenectomy). Cohort 2: Healthy volunteers who are UHNM staff members ≥ 18 years old, with no known contraindication to MRI. Volunteers will be age and gender matched to the participants in cohort 1.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MRS scan
Diagnostic testMagnetic Resonance Spectroscopy scan on the thigh
CPET
Diagnostic testCardiopulmonary Exercise Test
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Participants2 interventions
Group B: Healthy volunteers2 interventions
Trial outcomes
Primary outcomes
1
Correlations between levels
Calculate the correlation between the intramyocellular lipid (IMCL) saturation index and Cardiopulmonary Exercise Test (CPET) derived VO2max and Anaerobic Threshold (AT).
Time frame
2 yearsSecondary outcomes
1
Comparisons between participants who did not suffer major morbidity
Compare the mean Intra-Myocellular Lipid (IMCL) saturation index for patients who suffered major morbidity after oesophagectomy, gastrectomy, or pancreaticoduodenectomy and compare this to the mean IMCL saturation index of those who did not suffer major morbidity.
Time frame
2 years2
Short and long term repeatability
Assess the short- and long-term repeatability of Magnetic Resonance Spectroscopy (MRS) of Intra-Myocellular Lipid (IMCL) saturation index measurements in healthy volunteers. .
Time frame
2 years3
Difference in IMCL composition
Assess the difference in Intra-Myocellular Lipid (IMCL) composition between patients considered for surgery and age and gender matched volunteers
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov