50 Participants NeededMy employer runs this trial

DCE-MRI for Pancreatic Cancer

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Overseen ByThe Ohio State University Comprehensive Cancer Center
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively a special type of MRI scan, called dynamic contrast enhanced MRI (DCE-MRI), assesses the response of pancreatic cancer treatments. It targets individuals with a type of pancreatic cancer that may be surgically removable with appropriate treatment. Participants will receive standard treatments, including chemotherapy drugs such as Fluorouracil, Gemcitabine, Irinotecan, Nab-paclitaxel, and Oxaliplatin. The DCE-MRI will assist doctors in understanding the cancer's response. Ideal candidates have pancreatic cancer affecting nearby arteries or veins but no distant disease spread. As a Phase 1, Phase 2 trial, this research focuses on understanding the treatment's effects in people and measuring its effectiveness in an initial, smaller group.

What prior data suggests that DCE-MRI is safe for assessing treatment response in pancreatic cancer?

Research has shown that the treatments in this study—Fluorouracil, Gemcitabine, Irinotecan, Nab-paclitaxel, and Oxaliplatin—have varying safety levels based on past studies.

Fluorouracil has been widely used in studies for pancreatic cancer. It can cause side effects like reduced bone marrow activity, tiredness, and vomiting. However, the FDA has approved it for several cancers, including pancreatic cancer, indicating it is generally safe under medical supervision.

Gemcitabine is another well-studied drug. Research indicates that its side effects are usually moderate and manageable. It is often used with Nab-paclitaxel, a combination approved by the FDA for pancreatic cancer, suggesting it is safe when used correctly.

Irinotecan has been part of cancer treatments for some time. It may cause side effects like diarrhea and a low white blood cell count, but its FDA approval shows that its benefits in treating cancers are well-recognized.

Nab-paclitaxel, commonly used with Gemcitabine, generally has manageable side effects with proper monitoring. This combination has been shown to increase survival in pancreatic cancer patients, indicating its effectiveness and relative safety.

Oxaliplatin is often used in combination therapies. It is generally considered tolerable, with side effects that can be effectively controlled.

In summary, each of these treatments has been thoroughly studied and is considered safe for use in controlled clinical settings. Participants in trials can expect careful monitoring to manage any possible side effects.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it uses DCE-MRI, a dynamic contrast-enhanced imaging technique, to better understand how pancreatic cancer responds to treatment. Unlike traditional imaging methods, DCE-MRI provides detailed insights into tumor blood flow and vascular characteristics, potentially leading to more personalized treatment strategies. By combining this advanced imaging with standard chemotherapy options like gemcitabine, nab-paclitaxel, and others, researchers hope to improve the precision and effectiveness of pancreatic cancer therapies.

What evidence suggests that DCE-MRI is effective for assessing treatment response in pancreatic cancer?

Research has shown that combining the drugs fluorouracil and irinotecan, often with leucovorin, can extend the lives of patients with advanced pancreatic cancer. In this trial, participants may receive this combination as part of their standard care. Studies have also found that using gemcitabine with nab-paclitaxel significantly improves survival rates compared to gemcitabine alone, making it another treatment option in this trial. Additionally, oxaliplatin, when combined with other drugs like gemcitabine, has effectively treated advanced pancreatic cancer, benefiting many patients. These treatments typically aim to shrink tumors or slow their growth, improving the chances of successful surgery for patients with pancreatic cancer that is nearly but not quite removable.678910

Who Is on the Research Team?

SR

Shafia Rahman, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with pancreatic cancer that might be removable by surgery (borderline resectable). Participants should be healthy enough for imaging and treatment, and not have conditions or allergies that would interfere with MRI scans or the study drugs.

Inclusion Criteria

Written informed consent and HIPAA authorization for release of personal health information
I am 18 years old or older.
My cancer has not spread to other parts of my body.
See 19 more

Exclusion Criteria

My cancer has spread to other parts of my body.
Unwillingness or inability to comply with study procedures
I have not had another cancer in the past two years, except certain skin or cervical cancers.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Pre-Treatment Imaging

Patients receive gadolinium based contrast IV and undergo DCE-MRI

1 day
1 visit (in-person)

Treatment

Patients undergo standard of care treatment with gemcitabine and nab paclitaxel or fluorouracil, oxaliplatin, irinotecan and leucovorin

6 weeks
Multiple visits (in-person)

Post-Treatment Imaging

Approximately 6 weeks after therapy initiation and again within 1 week prior to surgery, patients receive gadolinium based contrast IV and undergo DCE-MRI

1 week
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Biospecimen Collection
  • Computed Tomography
  • Dynamic Contrast-Enhanced Magnetic Resonance Imaging
  • Fluorouracil
  • Gadolinium-Chelate
  • Gemcitabine
  • Irinotecan
  • Leucovorin Calcium
  • Nab-paclitaxel
  • Oxaliplatin
  • Point-of-care portable perfusion phantom (P4)

Trial Overview

The study is testing if using a special type of MRI scan (DCE-MRI) along with standard tests can better assess how well pre-surgery chemotherapy works in borderline resectable pancreatic cancer. Patients receive common chemo drugs and undergo advanced imaging.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Diagnostic (DCE-MRI)Experimental Treatment11 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Citations

Quality of life in metastatic pancreatic cancer patients ...

The NAPOLI-1 study (NCT01494506) reported that liposomal irinotecan plus 5-fluorouracil and leucovorin (nal-IRI+5-FU/LV) improved overall survival vs ...

Long-term survival in patients with pancreatic cancer treated ...

The median OS of long-term survivors was 17.6 months (95% CI 14.2 to NA months), compared with a median OS of 4.3 months (95% CI 2.8-5.3 months) ...

Liposomal Irinotecan Plus 5-FU Shows Real-World OS ...

Patients who were administered at least 4 cycles of liposomal irinotecan had an estimated 1-year OS rate of 29.1% (95% CI, 24.0%-34.3%), while ...

A Meta-Analysis of Randomized Controlled Trials | PLOS One

GEM combined with fluorouracil drugs significantly improved OS and increased one-year survival rate and ORR compared to GEM alone in LA/MPC patients.

New implications from long-term outcomes of perioperative ...

a 3-year overall survival of 63.4% compared to 48.6% using gemcitabine ・ 5 year overall survival rates of 38% and 31% respectively ・ a 5 year ...

A Randomised Study of continuous infusion 5-Fluorouracil ...

A Randomised Study of continuous infusion 5-Fluorouracil (5FU) with or without bolus Mitomycin-C in Patients with Advanced Pancreatic Cancer ; ISRCTN61961630.

Safety and efficacy of modified FOLFIRINOX in pancreatic ...

The regimen was associated with significant grade 3/ 4 toxicities, such as myelosuppression(46%), fatigue(24%), vomiting(15%) and diarrhea (13%) ...

Conditions for effective use of liposomal irinotecan with ...

We evaluated the efficacy and safety of nal-IRI + 5FU/LV in patients with unresectable PDAC who received previous FOLFIRINOX therapy and those ...

Combination 5-fluorouracil, folinic acid and cisplatin (LV5FU2 ...

Cisplatin combined with 5FU appears promising in metastatic pancreatic carcinoma, with a 26% response rate with a median survival of 7 months in ...

Low-Dose Continuous 5-Fluorouracil Combined with ...

In this paper we report the results of a retrospective analysis of 65 patients with advanced metastatic or locally advanced incurable pancreatic ...