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NCT Number: NCT06544187

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

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.

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Key information

Conditions

Surgical Fitness Imaging

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals of North Midlands NHS Trust

Stoke-on-Trent, United Kingdom

Location status: Recruiting

Location contact

Aviva Ogbolosingha

CONTACT

[email protected]

01782 675380

Sam Butler

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRS scan

Diagnostic Test

Magnetic Resonance Spectroscopy scan on the thigh

CPET

Diagnostic Test

Cardiopulmonary Exercise Test

Primary outcomes

  1. Correlations between levels

    Time frame: 2 years

    Calculate the correlation between the intramyocellular lipid (IMCL) saturation index and Cardiopulmonary Exercise Test (CPET) derived VO2max and Anaerobic Threshold (AT).

Secondary outcomes

  1. Comparisons between participants who did not suffer major morbidity

    Time frame: 2 years

    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.

  2. Short and long term repeatability

    Time frame: 2 years

    Assess the short- and long-term repeatability of Magnetic Resonance Spectroscopy (MRS) of Intra-Myocellular Lipid (IMCL) saturation index measurements in healthy volunteers.

    .

  3. Difference in IMCL composition

    Time frame: 2 years

    Assess the difference in Intra-Myocellular Lipid (IMCL) composition between patients considered for surgery and age and gender matched volunteers

Study contacts

Contact information is provided by the study sponsor or research team.

Aviva Ogbolosingha

CONTACT

[email protected]

01782 675380

Sponsors and collaborators

Lead sponsor

University Hospitals of North Midlands NHS Trust

Other

Registry information

Acronym: RESPIRE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 9, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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