Clinical trial NCT06544187: Can Imaging be an Alternative to Exercise Testing as a Predictor of Surgical Fitness?
Official title: Can Imaging be an Alternative to Exercise Testing as a Predictor of Surgical Fitness?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgical Fitness
Imaging
Lead sponsor: University Hospitals of North Midlands NHS Trust
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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: Inclusion Criteria:

Inclusion criteria for patients (cohort 1)

* Patients diagnosed oesophageal/gastric or pancreatic cancer.
* Patients who have or a under consideration for a CPET investigation.
* Aged ≥ 18.
* Existing UHNM Patient.
* Willing and able to give fully informed consent.
* Willing and able to comply with the study procedures.

Inclusion criteria for staff volunteers (cohort 2)

* Aged ≥ 18 years.
* Willing and able to give fully informed consent.
* Willing and able to comply with the study procedures.
* UHNM member of staff.

Exclusion Criteria:

Exclusion criteria for patients (cohort 1)

* 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.
* Patients not referred for CPET investigations.
* Patients that are pregnant.
* Patients that are unable to communicate in English.
* Patients lacking the capacity and capability to give fully informed consent.
* Patients participating in any other interventional studies with a contraindication to their participation.
* Patients for whom the addition of an MRS scan would delay any part of their standard treatment pathway.
* History of diabetes.

Exclusion criteria for staff volunteers (cohort 2)

* Volunteers with contraindications to MRI due to safety at 3T.
* Volunteers with metalwork within the imaging field of view (e.g., knee replacement).
* Claustrophobic volunteers.
* Volunteers outside of stated age range to ensure informed consent.
* Volunteers that are pregnant.
* Volunteers that are unable to communicate in English.
* Volunteers lacking the capacity and capability to give fully informed consent.
* Volunteers participating in any other interventional studies with a contraindication to their participation.
* Known or suspected medical conditions pertinent to the area being scanned.
* History of diabetes.

Primary outcomes:
measure: Correlations between levels
timeFrame: 2 years
Secondary outcomes:
measure: Comparisons between participants who did not suffer major morbidity
timeFrame: 2 years
measure: Short and long term repeatability
timeFrame: 2 years
measure: Difference in IMCL composition
timeFrame: 2 years
Other outcomes:
Locations:
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust
Study officials:
References: