NCT05669287

Brief Summary

With CT-perfusion(CTP) it is possible to visualize the enhancement pattern of the tumor. The perfusion CT, interleaved with a routine contrast enhanced CT (CECT) will be performed at diagnosis in all patients (goal: n=125 patients) and at the first follow-up at 3 months in patients treated with systemic therapy (goal: n=50 patients). Also, the histopathology will be collected for resected tumors to perform histopathology analysis. CTP parameters will be correlated to immunohistological findings and clinical outcome. The main goal of the study is to create an AI-assisted method to classify patients with a vascular phenotype of pancreatic ductal adenocarcinoma (PDAC). The investigators expect that this phenotype can be used to predict overall survival and chemotherapy response.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2017

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 30, 2022

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

May 3, 2023

Status Verified

December 1, 2022

Enrollment Period

5 years

First QC Date

December 20, 2022

Last Update Submit

May 1, 2023

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma

Keywords

PancreasPancreatic cancerCT perfusionHistopathologyImaging Biomarker

Outcome Measures

Primary Outcomes (2)

  • Classification of vascular phenotype using CT-perfusion

    To classify a vascular phenotype with CTP using automated perfusion analysis in patients with pancreatic ductal adenocarcinoma

    Baseline

  • Correlation of CT-perfusion features with histopathological features

    To correlate the vascular phenotype with histopathologic features (stroma and microvessel density) in patients with pancreatic ductal adenocarcinoma

    Baseline, Time of Resection

Secondary Outcomes (3)

  • Association between survival and CT-perfusion features

    Baseline, at 2 Years

  • Prediction of chemotherapy response

    Baseline, 3 Months

  • Prediction of chemotherapy response compared to RECIST

    Baseline, 3 Months, 6 Months

Study Arms (1)

CT Perfusion

EXPERIMENTAL

All patients will receive a baseline CT Perfusion scan. A subgroup of patients with chemotherapy treatment will receive a follow-up CT Perfusion after 3 months.

Diagnostic Test: CT Perfusion

Interventions

CT PerfusionDIAGNOSTIC_TEST

CT Perfusion

CT Perfusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical suspicion of pancreatic cancer
  • years and older
  • written (signed and dated) informed consent

You may not qualify if:

  • Contra-indications to undergo CT (due to untreatable contrast allergy or renal function impairment)
  • Previous treatment for pancreatic cancer
  • Concomitant malignancies. Subjects with prior malignancies must be disease-free for at least 5 years
  • Insufficient command of the Dutch language to be able to understand the patient information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Hospital

Nijmegen, Gelderland, 6525GA, Netherlands

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • John Hermans, MSc, MD, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Henkjan Huisman, MSc, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Lodewijk Brosens

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tom Perik, Msc.

CONTACT

024 3617899tom.perik@radboudumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2022

First Posted

December 30, 2022

Study Start

December 22, 2017

Primary Completion

December 31, 2022

Study Completion

June 1, 2023

Last Updated

May 3, 2023

Record last verified: 2022-12

Locations

NL(1)