Exploring MRI as a Predictor of Surgical Fitness

Can Imaging be an Alternative to Exercise Testing as a Predictor of Surgical Fitness?

This study is testing if MRI can be used instead of a tough exercise test to see if patients with gastric, oesophageal, or pancreatic cancer are fit enough for surgery.

Quick facts

• Study type: Observational
• Enrollment: 56 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospitals of North Midlands NHS Trust (Academic / other)
• Locations: 1 site (Stoke-on-Trent)
• Trial ID: NCT06544187 on ClinicalTrials.gov

What this trial studies

This study investigates whether Magnetic Resonance Imaging (MRI) can serve as an alternative to Cardiopulmonary Exercise Testing (CPET) for assessing surgical fitness in patients with gastric, oesophageal, or pancreatic cancer. CPET is a demanding exercise test that measures a patient's maximum oxygen consumption and anaerobic threshold, which are critical for determining their ability to tolerate surgery. The study aims to evaluate the effectiveness of MRI in predicting surgical readiness, particularly for patients who may not be able to undergo traditional exercise testing due to physical limitations. By comparing MRI results with CPET outcomes, the research seeks to identify a less physically taxing method for evaluating surgical candidates.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with oesophageal, gastric, or pancreatic cancer who are being considered for CPET.

Not a fit: Patients with contraindications to MRI, such as those with metal implants or claustrophobia, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a less strenuous and more accessible method for assessing surgical fitness in patients with cancer.

How similar studies have performed: While traditional methods like CPET are well-established, the use of MRI as a predictor of surgical fitness is a novel approach that has not been extensively tested.

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.

Where this trial is running

Stoke-on-Trent

• University Hospitals of North Midlands NHS Trust — Stoke-on-Trent, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Aviva Ogbolosingha

Conditions Surgical Fitness; Imaging