Pancreatic Ductal AdenocarcinomaAIR-PANCNCT05727319
Advances in Imaging to Assess Response in Pancreatic Cancer (AIR-PANC)
An observational study of Pancreatic Ductal Adenocarcinoma, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial summary
The goal of this observational study is to determine the feasibility of acquiring serial MRI images for longitudinal analysis in pancreatic ductal adenocarcinoma (PDAC) patients. The main question it aims to answer: Is it feasible to acquire baseline and repeat MR images in Radiotherapy treatment position? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Nov 2022to 20 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: PDAC patients scheduled to undergo RT +/- chemotherapy at the BWOSCC will be recruited where eligibility criteria are met. These patients will have confirmed pancreatic ductal adenocarcinoma (PDAC) which is locally advanced pancreatic cancer (LAPC), or borderline resectable pancreatic cancer (BRPC). Study duration is expected to be 18 months from first patient recruited.
Who may be able to join
- Histologically confirmed localised PDAC -as determined by the West of Scotland Hepato-Pancreatobiliary (HPB) MDT
- Scheduled to undergo RT +/- chemotherapy
- 18 years of age or older
- Measurable disease on imaging
- Able to give written informed consent
- Patients willing and able to comply with the protocol for the duration of the study
Who cannot join
- Distant metastatic disease
- Other severe or uncontrolled systemic disease or evidence of any other significant disorder or lab finding that makes it undesirable for the patient to participate in the study, as determined by the treating physician.
- History of physical or psychiatric disorder that would prevent informed consent and compliance with protocol
- Major surgery within 28 days prior to trial entry
- Any contraindication to MR
- MRI unsafe implants, ferrous metal in the body, insufficient information on previous surgeries, MRI conditional implants where the conditions cannot be met (e.g. pacemakers).
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Beatson West of Scotland Cancer Centre
Glasgow, G120YN
About this study
Official title: Advances in Imaging to Assess Response in Pancreatic Cancer (AIR-PANC): a Single Centre Feasibility Study
The goal of this observational study is to determine the feasibility of acquiring serial MRI images for longitudinal analysis in pancreatic ductal adenocarcinoma (PDAC) patients. The main question it aims to answer:
Is it feasible to acquire baseline and repeat MR images in Radiotherapy treatment position?
Read the detailed description
PDAC is one of the leading causes of cancer deaths in the UK, with the number of deaths resembling the number of new cases each year. Long term survival is poor, with around 3% of patients alive at 5 years, reducing to 1% at 10 years. Outcomes have shown minor improvement over the past few decades, with little impact in survival being achieved. This is a worldwide problem, with pancreatic cancer being 7th cause of cancer death.
Although progress has been made in terms of assessing the molecular profiling of pancreatic cancer, there has been little progress in some of the clinical aspects e.g. optimal radiological assessment to stratify patients. Currently imaging criteria following neo-adjuvant treatment has been shown to be sub-optimal in accurately defining response to treatment, which may prevent patients from receiving the treatment that gives them the best outcomes. The emerging paradigm in using pre-operative treatment (chemotherapy +/- RT) to improve outcomes for patients is likely to become the standard of care, increasing the need for advanced imaging assessments that accurately stratify patients by enhancing what is currently assessable on morphological images.
Quantified imaging biomarkers (QIMB) and radiomics are a highly promising area of RT research which will enhance the future direction of personalised treatment. Groups have used said research to examine tumour response; predict toxicity; and adapt RT for some anatomical sites. However, this area of research is particularly challenging in the abdomen, where many uncertainties exist, e.g. motion of pancreas and organs at risk; and poor image quality due to motion artefacts on imaging. New promising data is emerging from centres where patients are being treated with MR guided radiotherapy (MRgRT) systems. These include serial image analysis using delta radiomics that can predict early response in tumour; and feasibility of acquiring functional MR throughout treatment that shows apparent diffusion coefficient (ADC) change in tumour and a correlation to response. Very little work has been done to measure ADC changes during RT and this is where potential to adapt RT lies.
Diffusion MRI (dMRI) allows increased monitoring of functional changes during or post RT by providing information on the biological characteristics of tissue. Recent data even shows promise in the correlation of treatment outcome to ADC measured or compared pre and post RT, by correlating change in ADC to pathologic response; as a tool to predict patients likely to have a successful R0 resection; and in predicting patients who will not respond to CRT and may require a different disease management.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- PDAC
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproduciblity
The proportion of patients who have successfully completed acquisition of a baseline and week 1 repeat scans
Measured: 18 months
Volumetric and functional feasibility
The proportion of patients where volumetric and functional measurements are reproducible between baseline and repeat scans
Measured: 18 months
Region of interest quantifiability
The proportion of patients where a region of interest can be created and quantified imaging parameters (e.g. ADC) can be extracted on baseline and repeat imaging
Measured: 18 months
Secondary outcomes (3)
Image parameter extraction
The proportion of patients where a region of interest (ROI) can be created and quantified imaging parameters (e.g. ADC) can be extracted on baseline and repeat imaging
Measured: 18 months
Morphological data
The proportion of patients where change in ADC pre and post RT correlate to RECIST from SOC to follow up
Measured: 18 months
Reproducibility of motion corrected/gated image acquisition
The proportion of patients where key features can be tested on larger data sets
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start17 Nov 2022
- Primary completion17 May 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies 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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aileen Duffton, Study chair, Chief Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727319
- Sponsor's protocol ID
- GN21ON523
- Acronym
- AIR-PANC
- Status last verified
- Feb 2025
- First submitted
- 11 Jan 2023
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advances in Imaging to Assess Response in Pancreatic Cancer (AIR-PANC): a Single Centre Feasibility Study
- ClinicalTrials.gov ID
- NCT05727319
- Acronym / sponsor ID
- AIR-PANC / GN21ON523
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- PDAC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Study start
- 17 Nov 2022 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 14 Feb 2023 (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.
The goal of this observational study is to determine the feasibility of acquiring serial MRI images for longitudinal analysis in pancreatic ductal adenocarcinoma (PDAC) patients. The main question it aims to answer:
Is it feasible to acquire baseline and repeat MR images in Radiotherapy treatment position?
Detailed description
PDAC is one of the leading causes of cancer deaths in the UK, with the number of deaths resembling the number of new cases each year. Long term survival is poor, with around 3% of patients alive at 5 years, reducing to 1% at 10 years. Outcomes have shown minor improvement over the past few decades, with little impact in survival being achieved. This is a worldwide problem, with pancreatic cancer being 7th cause of cancer death.
Although progress has been made in terms of assessing the molecular profiling of pancreatic cancer, there has been little progress in some of the clinical aspects e.g. optimal radiological assessment to stratify patients. Currently imaging criteria following neo-adjuvant treatment has been shown to be sub-optimal in accurately defining response to treatment, which may prevent patients from receiving the treatment that gives them the best outcomes. The emerging paradigm in using pre-operative treatment (chemotherapy +/- RT) to improve outcomes for patients is likely to become the standard of care, increasing the need for advanced imaging assessments that accurately stratify patients by enhancing what is currently assessable on morphological images.
Quantified imaging biomarkers (QIMB) and radiomics are a highly promising area of RT research which will enhance the future direction of personalised treatment. Groups have used said research to examine tumour response; predict toxicity; and adapt RT for some anatomical sites. However, this area of research is particularly challenging in the abdomen, where many uncertainties exist, e.g. motion of pancreas and organs at risk; and poor image quality due to motion artefacts on imaging. New promising data is emerging from centres where patients are being treated with MR guided radiotherapy (MRgRT) systems. These include serial image analysis using delta radiomics that can predict early response in tumour; and feasibility of acquiring functional MR throughout treatment that shows apparent diffusion coefficient (ADC) change in tumour and a correlation to response. Very little work has been done to measure ADC changes during RT and this is where potential to adapt RT lies.
Diffusion MRI (dMRI) allows increased monitoring of functional changes during or post RT by providing information on the biological characteristics of tissue. Recent data even shows promise in the correlation of treatment outcome to ADC measured or compared pre and post RT, by correlating change in ADC to pathologic response; as a tool to predict patients likely to have a successful R0 resection; and in predicting patients who will not respond to CRT and may require a different disease management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PDAC patients scheduled to undergo RT +/- chemotherapy at the BWOSCC will be recruited where eligibility criteria are met. These patients will have confirmed pancreatic ductal adenocarcinoma (PDAC) which is locally advanced pancreatic cancer (LAPC), or borderline resectable pancreatic cancer (BRPC). Study duration is expected to be 18 months from first patient recruited.
Key inclusion criteria (6 listed)
- Histologically confirmed localised PDAC -as determined by the West of Scotland Hepato-Pancreatobiliary (HPB) MDT
- Scheduled to undergo RT +/- chemotherapy
- 18 years of age or older
- Measurable disease on imaging
- Able to give written informed consent
Key exclusion criteria (6 listed)
- Distant metastatic disease
- Other severe or uncontrolled systemic disease or evidence of any other significant disorder or lab finding that makes it undesirable for the patient to participate in the study, as determined by the treating physician.
- History of physical or psychiatric disorder that would prevent informed consent and compliance with protocol
- Major surgery within 28 days prior to trial entry
- Any contraindication to MR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reproduciblity
Time frame: 18 months
The proportion of patients who have successfully completed acquisition of a baseline and week 1 repeat scans
Volumetric and functional feasibility
Time frame: 18 months
The proportion of patients where volumetric and functional measurements are reproducible between baseline and repeat scans
Region of interest quantifiability
Time frame: 18 months
The proportion of patients where a region of interest can be created and quantified imaging parameters (e.g. ADC) can be extracted on baseline and repeat imaging
3 secondary outcomes
Image parameter extraction
Time frame: 18 months
Morphological data
Time frame: 18 months
Reproducibility of motion corrected/gated image acquisition
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
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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. This study is not recruiting at the moment.
Aileen Duffton study chair
Chief Investigator
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 Pancreatic Ductal Adenocarcinoma, run by NHS Greater Glasgow and Clyde 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 7 Feb 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproduciblity (time frame: 18 months). The study lists 3 primary outcomes in all. 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 7 Feb 2025.