Surgical FitnessRESPIRENCT06544187
Can Imaging be an Alternative to Exercise Testing as a Predictor of Surgical Fitness?
An observational study of Surgical Fitness and Imaging, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgical Fitness, Imaging
- What is being tested?
- MRS scan and CPET
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jan 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- Aged ≥ 18 years.
- Willing and able to give fully informed consent.
- Willing and able to comply with the study procedures.
- UHNM member of staff.
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent
Aviva Ogbolosingha, 01782 675380, aviva.ogbolosingha@uhnm.nhs.uk
Sam Butler
About this study
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.
Read more
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.
- Conditions
- Surgical Fitness, Imaging
- Being tested
- MRS scan, CPET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRS scanDiagnostic test
Magnetic Resonance Spectroscopy scan on the thigh
CPETDiagnostic test
Cardiopulmonary Exercise Test
| Study group | Role | What they receive |
|---|---|---|
| Participants | The first phase of the study will involve 56 participants who are potential candidates for oesophagectomy, gastrectomy or pancreaticoduodenectomy procedures following a confirmed cancer diagnosis. Participants who provide their consent will undergo Magnetic Resonance Spectroscopy (MRS) scans of their semitendinosus muscle in the thigh. Participants on this pathway also undergo Cardiopulmonary Exercise Test (CPET) tests, which is a standard procedure. No delay to their normal treatment pathway will be introduced from the addition of the MRS scan, and MR scans can be arranged within two weeks from referral Receives: Diagnostic Test: MRS scan; Diagnostic Test: CPET | |
| Healthy volunteers | 25 healthy volunteers. Their role will be to help us understand the consistency in Intra-Myocellular Liquid (IMCL) composition using Magnetic Resonance Spectroscopy (MRS) techniques. These volunteers will be sourced from the UHNM Trust staff, in accordance with Trust Standard Operating Procedure (SOP): The Safe Scanning of Volunteers in Magnetic Resonance Imagine (MRI). Each volunteer will undergo two MRS scans initially. All three MRS scans will be performed in a single session, with the session lasting about 20 minutes. Additionally, each volunteer will return for a single repeat session of MRS acquisition using the same MRI system and protocol, scheduled at two weeks after the initial scans Receives: Diagnostic Test: MRS scan; Diagnostic Test: CPET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlations between levels
Calculate the correlation between the intramyocellular lipid (IMCL) saturation index and Cardiopulmonary Exercise Test (CPET) derived VO2max and Anaerobic Threshold (AT).
Measured: 2 years
Secondary outcomes (3)
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.
Measured: 2 years
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.
.
Measured: 2 years
Difference in IMCL composition
Assess the difference in Intra-Myocellular Lipid (IMCL) composition between patients considered for surgery and age and gender matched volunteers
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start6 Jan 2025
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical FitnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals of North Midlands NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544187
- Sponsor's protocol ID
- 3354
- Acronym
- RESPIRE
- Status last verified
- Mar 2026
- First submitted
- 1 Aug 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Imaging be an Alternative to Exercise Testing as a Predictor of Surgical Fitness?
- ClinicalTrials.gov ID
- NCT06544187
- Acronym / sponsor ID
- RESPIRE / 3354
- Conditions
- Surgical Fitness, Imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University Hospitals of North Midlands NHS TrustUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants | – | Diagnostic Test: MRS scan, Diagnostic Test: CPETThe first phase of the study will involve 56 participants who are potential candidates for oesophagectomy, gastrectomy or pancreaticoduodenectomy procedures following a confirmed cancer diagnosis. Participants who provide their consent will undergo Magnetic Resonance Spectroscopy (MRS) scans of their semitendinosus muscle in the thigh. Participants on this pathway also undergo Cardiopulmonary Exercise Test (CPET) tests, which is a standard procedure. No delay to their normal treatment pathway will be introduced from the addition of the MRS scan, and MR scans can be arranged within two weeks from referral |
| Healthy volunteers | – | Diagnostic Test: MRS scan, Diagnostic Test: CPET25 healthy volunteers. Their role will be to help us understand the consistency in Intra-Myocellular Liquid (IMCL) composition using Magnetic Resonance Spectroscopy (MRS) techniques. These volunteers will be sourced from the UHNM Trust staff, in accordance with Trust Standard Operating Procedure (SOP): The Safe Scanning of Volunteers in Magnetic Resonance Imagine (MRI). Each volunteer will undergo two MRS scans initially. All three MRS scans will be performed in a single session, with the session lasting about 20 minutes. Additionally, each volunteer will return for a single repeat session of MRS acquisition using the same MRI system and protocol, scheduled at two weeks after the initial scans |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRS scanMagnetic Resonance Spectroscopy scan on the thigh | Diagnostic test | Healthy volunteers, Participants |
| CPETCardiopulmonary Exercise Test | Diagnostic test | Healthy volunteers, Participants |
Primary outcome
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).
3 secondary outcomes
Comparisons between participants who did not suffer major morbidity
Time frame: 2 years
Short and long term repeatability
Time frame: 2 years
Difference in IMCL composition
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Individual participant dataSharing planned: No. Participant data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Fitness and Imaging, run by University Hospitals of North Midlands NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aviva Ogbolosingha (01782 675380, aviva.ogbolosingha@uhnm.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlations between levels (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.