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Contrast MRI for Pancreatic Cancer

N/A

Waitlist Available

Led By Lyndon Luk, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

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

Must have

No contraindication to MRI such as severe claustrophobia (not alleviated by oral anti-anxiolytics) or metal/mechanical devices in their body not considered magnetic resonance (MR) compatible at 1.5 Tesla (departmental MRI safety screening form)

18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two years

Awards & highlights

Study Summary

This trial will compare two types of MRI scans to see which is more effective in measuring pancreatic cancer.

Who is the study for?

This trial is for adults with confirmed or suspected pancreatic adenocarcinoma who are candidates for surgery. They must be able to undergo MRI scans, have no severe claustrophobia unrelieved by medication, no incompatible metal/mechanical devices in their body, and no allergy to gadolinium contrast agents. Participants need sufficient kidney function unless they can't receive contrast.Check my eligibility

What is being tested?

The study tests the effectiveness of MRI scans using different contrast agents as biomarkers in pancreatic cancer patients undergoing surgery. It aims to correlate MRI results with tissue characteristics like blood vessel density and fibrosis level to set a standard protocol for future trials.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to the gadolinium-based contrast agent used during the MRI scan, such as rash or itching. Kidney function might also be affected post-contrast administration but only participants with adequate kidney function will receive it.

Eligibility Criteria

Inclusion Criteria

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

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I can undergo an MRI; I don't have severe claustrophobia or incompatible devices in my body.

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I am 18 years old or older.

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I have been diagnosed with pancreatic cancer and am scheduled for surgery.

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My kidney function is good enough for contrast studies, or I can join without contrast if it's not.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

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

Treatment Details

Study Objectives

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

Primary outcome measures

Correlation between Apparent Diffusion Coefficient (ADC) of pancreatic cancer based on MRI with percent fibrosis at histopathology

Secondary outcome measures

Correlation between Ktrans of pancreatic cancer derived from dynamic contrast enhanced MRI performed with gadopentetate dimeglumine and mean vascular density quantified at histopathology.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Pancreatic Mass or Risk Factors GroupExperimental Treatment1 Intervention

Participants with pancreatic adenocarcinoma who are planning to undergo surgical resection. Participants will undergo up to two MRIs with and without intravenous contrast. The first MRI will be performed using an extracellular contrast agent and the second 1-14 days later, with a macromolecular contrast agent. If patient cannot undergo the second MRI for any reason eg. not enough time before surgery, one MRI with either contrast agent will still be used for analysis .

Group II: Healthy VolunteersActive Control1 Intervention

Normal volunteers with no pancreas mass or risk factors for pancreas cancer will be recruited for MRI protocol optimization and nothing more. No intravenous contrast will be given. They will be asked to lie in the scanner for up to 1 hour and non-contrast imaging will be performed.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,460,945 Total Patients Enrolled

Lyndon Luk, MDPrincipal InvestigatorCUIMC

Media Library

MRIs with and without intravenous contrast (up to 2) Clinical Trial Eligibility Overview. Trial Name: NCT02775786 — N/A

Pancreatic Adenocarcinoma Research Study Groups: Healthy Volunteers, Pancreatic Mass or Risk Factors Group

Pancreatic Adenocarcinoma Clinical Trial 2023: MRIs with and without intravenous contrast (up to 2) Highlights & Side Effects. Trial Name: NCT02775786 — N/A

MRIs with and without intravenous contrast (up to 2) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02775786 — 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 open enrollment slots in this research endeavor?

"From the details available on clinicaltrials.gov, this research endeavour is no longer recruiting patients after being posted on November 1st 2013 and last modified in mid-June 2020. However, numerous other studies are seeking volunteers to take part - 788 trials at present."

Answered by AI

Does this research include participants older than twenty years?

"This clinical trial is looking for participants aged 18 to 65."

Answered by AI

Are there any eligibility requirements for participants in this clinical experiment?

"This clinical trial is enrolling 70 patients with adenocarcinoma aged 18-65. To be eligible, applicants must adhere to the following criteria: being of legal age or above."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prospective Evaluation of MRI Biomarkers in Pancreatic Ductal Adenocarcinoma

Lyndon Luk, MD 2013. "Prospective Evaluation of MRI Biomarkers in Pancreatic Ductal Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02775786.