Advances in Imaging to Assess Response in Pancreatic Cancer (AIR-PANC)

NCT05727319 | Completed

• 1 other identifier: GN21ON523
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

PDAC

Outcome Measures

Primary Outcomes (3)

• Reproduciblity

  The proportion of patients who have successfully completed acquisition of a baseline and week 1 repeat scans

  18 months

• Volumetric and functional feasibility

  The proportion of patients where volumetric and functional measurements are reproducible between baseline and repeat scans

  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

  18 months

Secondary Outcomes (3)

• Image parameter extraction

  18 months

• Morphological data

  18 months

• Reproducibility of motion corrected/gated image acquisition

  18 months

Other Outcomes (4)

• Metabolic changes

  18 months

• Translational

  18 months

• Prognostic tool discernment

  18 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Histologically confirmed localised PDAC -as determined by the West of Scotland Hepato-Pancreatobiliary (HPB) MDT
• Scheduled to undergo RT +/- chemotherapy
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead

Study Sites (1)

Beatson West of Scotland Cancer Centre

Glasgow, G120YN, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample and biopsy tissue

Study Officials

• Aileen Duffton

  Chief Investigator

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: February 14, 2023
• Study Start: November 17, 2022
• Primary Completion: May 17, 2024
• Study Completion: December 20, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

GB (1)