Assessing stromal architecture with MR Elastography to predict cytotoxic treatment efficacy in pancreatic cancer: validation

Assessing stromal architecture with MR Elastography to predict cytotoxic treatment efficacy in pancreatic cancer: validation - ASAP: validation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54349

Enrollment

Registered

2020-08-27

Start date

2021-06-10

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas adenocarcinoma Pancreatic cancer

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: All sub-studies • 18 years or older • Written informed consent Sub-study I • Healthy volunteers: negative history for any pancreatic diseases (including diabetes mellitus) Sub-study II • Scheduled for a resection of the pancreatic ductal adenocarcinoma Sub-studies III • A (patient study): subjects have been diagnosed with pancreatic ductal adenocarcinoma • B (healthy volunteers): negative history for any pancreatic diseases (including diabetes mellitus)

Exclusion criteria

Exclusion criteria: All sub-studies • General MRI contraindications (including patients with a pacemaker, cochlear implant or *neurostimulator; patients with non-MR compatible metallic implants in their eye, spine, thorax or abdomen; or a non-MR compatible aneurysm clip in their brain; patients with severe claustrophobia). Sub-study II • History of allergic reaction to Gadolinium-containing compounds. • Renal failure (eGFR

Design outcomes

Primary

Measure	Time frame
Sub-study I: A robust MRE scan protocol, resulting in reproducible quantitative tissue stiffness [kPa] for healthy pancreatic tissue comparable to literature reported values Sub-study II: Correlation between quantitative mechanical tissue parameters derived in vivo (MRE) and ex vivo (biomechanical material properties on surgical specimens) assessed on average difference. Sub-study III: Within-session and -scan and between-session reproducibility and repeatability based on linear regression and Bland-Altman models. Assessed by limits of agreement, bias and the level of significance (P-value) as the end study parameters.	—

Measure

Time frame

Sub-study I: A robust MRE scan protocol, resulting in reproducible quantitative tissue stiffness [kPa] for healthy pancreatic tissue comparable to literature reported values Sub-study II: Correlation between quantitative mechanical tissue parameters derived in vivo (MRE) and ex vivo (biomechanical material properties on surgical specimens) assessed on average difference. Sub-study III: Within-session and -scan and between-session reproducibility and repeatability based on linear regression and Bland-Altman models. Assessed by limits of agreement, bias and the level of significance (P-value) as the end study parameters.

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Secondary

Measure	Time frame
Sub-Study II: For DWI the mean ADC of the whole tumour will be taken as secondary study endpoint. For DCE the tissue perfusion parameters will be the secondary study endpoints.	—

Countries

Netherlands

Outcome results