← Back to Search

Device

Pressure-enabled Drug Delivery for Liver Cancer (PEDIR Trial)

Q: What is the limit to the number of individuals who may be enrolled in this medical trial?

<p>Correct. According to clinicaltrials.gov, this medical experiment is actively seeking 20 participants from a single site and was first published on March 1st 2022 before being updated on May 17th 2022.</p>

Q: Are there any unfilled positions available for patients to participate in this clinical trial?

<p>Affirmative. According to the information available on clinicaltrials.gov, this trial is open for enrollment with a start date of March 1st 2022 and an update posted on May 17th 2022. 20 individuals are needed at one medical site in order to advance research objectives.</p>

N/A

Recruiting

Led By Patrick D Sutphin, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

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

Must have

Adequate organ and marrow function as defined below: International Normalized Ratio (INR): ≤ 1.5; Hemoglobin: ≥ 8.5 g/dL; Leukocytes: ≥2,000/mcL; Absolute neutrophil count: ≥1,00/mcL; Platelets: ≥50,000/mcL(after transfusion, if necessary); Total bilirubin: ≤2.0 mg/dL; Albumin: ≥3 g/dL; AST(SGOT)/ALT(SGPT): ≤6 × institutional ULN; Glomerular filtration rate (GFR): 30 mL/min/1.73 m2; Child Pugh Score A, or B7 with bilirubin ≤ 2 mg/dL.

Child Pugh Score A, or B7 with bilirubin ≤ 2 mg/dL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

PEDIR Trial Summary

This trial will compare two types of catheters to see which is better at delivering radioactivity to tumors in people with liver cancer.

Who is the study for?

Adults with liver cancer or colorectal metastases to the liver, who can't have surgery or thermal ablation. They should be in relatively good health (ECOG <2), with a life expectancy over 16 weeks and adequate organ function. Participants must not be pregnant, nursing, or planning to conceive soon. Those with stable extrahepatic disease may qualify.Check my eligibility

What is being tested?

The study is testing whether using a Pressure Enabled Drug Delivery (PEDD) device during mapping for radioembolization improves treatment delivery to liver tumors compared to a standard microcatheter.See study design

What are the potential side effects?

Potential side effects are related to catheter use and radioembolization procedures, which may include abdominal pain, nausea, fever post-procedure (post-embolization syndrome), and potential risks associated with radiation exposure.

PEDIR Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My blood tests meet the required levels for organ and marrow function.

Select...

My liver function is moderately to mildly impaired.

Select...

I can do most of my daily activities by myself.

Select...

I have been recommended for treatment with radioembolization.

Select...

My liver cancer is at an early to intermediate stage.

Select...

My liver cancer cannot be cured with surgery or heat-based treatments.

Select...

I have been recommended for treatment with radioembolization.

Select...

My liver cancer is at an early to intermediate stage.

Select...

My liver disease can be seen and measured on a scan.

Select...

I am 18 years old or older.

Select...

My disease can be seen and measured in my liver on a scan.

Select...

I am 18 years old or older.

Select...

My liver cancer cannot be cured with surgery or heating techniques.

Select...

I can do most of my daily activities without help.

PEDIR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Radiotracer distribution

Secondary outcome measures

Mapping procedure comparison of Tumor to Normal (T:N) ratio between standard microcatheter and pressure-enabled delivery catheter

Technical success of radiotracer delivery as measured by ability to deliver radiotracer

PEDIR Trial Design

2Treatment groups

Experimental Treatment

Group I: Sequence B: PEDD device for Mapping #1 and standard microcatheter for Mapping #2.Experimental Treatment2 Interventions

Participants with either hepatocellular carcinoma (HCC) or colorectal liver metastases tumors receiving standard of care radioembolization treatment will be randomly assigned to undergo a routine mapping procedure first using the PEDD device catheter 2-21 days before their radioembolization treatment day. Then on day of radioembolization treatment, an extra mapping procedure using a standard microcatheter will be done just prior to the treatment.

Group II: Sequence A: Standard microcatheter for Mapping #1 and PEDD device for Mapping #2.Experimental Treatment2 Interventions

Participants with either hepatocellular carcinoma (HCC) or colorectal liver metastases tumors receiving standard of care radioembolization treatment will be randomly assigned to undergo a routine mapping procedure first using a standard microcatheter 2-21 days before their radioembolization treatment day. Then on day of radioembolization treatment, an extra mapping procedure using the PEDD device catheter will be done just prior to the treatment.

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,933 Previous Clinical Trials

13,198,461 Total Patients Enrolled

TriSalus Life SciencesUNKNOWN

3 Previous Clinical Trials

27 Total Patients Enrolled

Patrick D Sutphin, MD, PhDPrincipal InvestigatorMassachusetts General Hospital

Media Library

PEDD device (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05128032 — N/A

Colorectal Cancer Research Study Groups: Sequence A: Standard microcatheter for Mapping #1 and PEDD device for Mapping #2., Sequence B: PEDD device for Mapping #1 and standard microcatheter for Mapping #2.

Colorectal Cancer Clinical Trial 2023: PEDD device Highlights & Side Effects. Trial Name: NCT05128032 — N/A

PEDD device (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05128032 — N/A

Frequently Asked Questions

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

What is the limit to the number of individuals who may be enrolled in this medical trial?

"Correct. According to clinicaltrials.gov, this medical experiment is actively seeking 20 participants from a single site and was first published on March 1st 2022 before being updated on May 17th 2022."

Answered by AI

Are there any unfilled positions available for patients to participate in this clinical trial?

"Affirmative. According to the information available on clinicaltrials.gov, this trial is open for enrollment with a start date of March 1st 2022 and an update posted on May 17th 2022. 20 individuals are needed at one medical site in order to advance research objectives."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pressure-enabled Delivery in Radioembolization (TriNav Study)

Patrick D. Sutphin, M.D. 2022. "Pressure-enabled Delivery in Radioembolization (TriNav Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05128032.

All > Colorectal Cancer Boston