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P4 Diagnostic Tool for Pancreatic Cancer

N/A

Recruiting

Led By Harrison Kim, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy volunteers aged 19 or older with no known major health problems

Patients with biopsy proven locally advanced pancreatic cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 7-days (mri number 3)

Awards & highlights

Study Summary

This trial is important because it will help to establish whether the P4 can be used to accurately assess the therapeutic response of pancreatic tumors. The P4 has great potential for widespread and routine clinical use for accurate diagnosis, prognosis and therapy monitoring.

Who is the study for?

This trial is for healthy adults over 19 with no major health issues and patients with advanced pancreatic cancer confirmed by biopsy. It's not for pregnant or breastfeeding individuals, those who may father a child, anyone with significant health problems, MRI contraindications, or severe kidney issues.Check my eligibility

What is being tested?

The study tests if a new device called P4 can improve the accuracy of DCE-MRI scans in monitoring pancreatic cancer therapy. Healthy volunteers will first use it at three locations to set baselines before patients with pancreatic cancer use it at one location.See study design

What are the potential side effects?

Since this trial involves standard DCE-MRI procedures and testing a non-invasive device (P4), there are minimal side effects expected beyond typical MRI-related discomforts such as claustrophobia or noise exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 19 or older and in good health with no major health issues.

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My pancreatic cancer is advanced but has not spread far.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measure change in blood flow within the pancreatic cancer as measured by the P4.

Reproducibility of quantitative DCE-MRI measurement with MRI 1.

Reproducibility of quantitative DCE-MRI measurement with MRI 2.

+1 more

Trial Design

2Treatment groups

Active Control

Group I: Healthy VolunteersActive Control1 Intervention

Group II: Pancreatic Cancer ParticipantsActive Control1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,590 Previous Clinical Trials

2,281,299 Total Patients Enrolled

Harrison Kim, PhD3.415 ReviewsPrincipal Investigator - University of Alabama at Birmingham

University of Alabama at Birmingham

2 Previous Clinical Trials

62 Total Patients Enrolled

1Patient Review

The staff's attitude was very off-putting. I had significant trouble trying to schedule appointments, and they were unwilling to work with me even though it was their mistake. It felt like they didn't think I had a say in which doctor I saw. While I did like Dr. Kim, I ultimately left because of these issues.

Media Library

Healthy Volunteers Clinical Trial Eligibility Overview. Trial Name: NCT04588025 — N/A

Pancreatic Cancer Research Study Groups: Healthy Volunteers, Pancreatic Cancer Participants

Pancreatic Cancer Clinical Trial 2023: Healthy Volunteers Highlights & Side Effects. Trial Name: NCT04588025 — N/A

Healthy Volunteers 2023 Treatment Timeline for Medical Study. Trial Name: NCT04588025 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings left for this research initiative?

"Clinicaltrials.gov provides evidence that this medical study, which was initially posted on October 14th 2020, is still recruiting participants. The trial's most recent update was made on November 3rd 2022."

Answered by AI

How many participants is this clinical trial accommodating?

"Affirmative. According to clinicaltrials.gov, this medical investigation went live on October 14th 2020 and remains active as of November 3rd 2022. 2 medical centres are currently searching for 55 participants to partake in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Disposable Perfusion Phantom for Accurate DCE (Dynamic Contrast Enhanced)-MRI Measurement of Pancreatic Cancer Therapy Response

Harrison Kim 2020. "Disposable Perfusion Phantom for Accurate DCE (Dynamic Contrast Enhanced)-MRI Measurement of Pancreatic Cancer Therapy Response". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04588025.