Liver CancerPEDIRNCT05128032
Pressure-enabled Delivery in Radioembolization (TriNav Study)
A study testing Standard microcatheter and PEDD device in people with Liver Cancer and Hepatocellular Carcinoma, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
The purpose of the study is to determine if the type of catheter used in the mapping procedure prior to radioembolization improves the delivery of radioactivity to tumor(s) in participants with liver cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer, Hepatocellular Carcinoma, Metastatic Colorectal Cancer
- What is being tested?
- Standard microcatheter and PEDD device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2022to 16 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Known HCC or CLM that are not amenable to curative resection or thermal ablative techniques such as microwave ablation.
- Prior clinical decision for treatment by radioembolization.
- Disease that is visible on CT or MRI as well as measurable disease in the liver. Measurable is defined as at least one lesion in the expected treatment field that can be accurately measured in at least one dimension (longest diameter) as (≥1 cm) with CT scan or MRI.
- Age ≥18 years. Because there is limited data with respect to radioembolization in patients <18 years of age with respect to tumor dosimetry and associated adverse events participants <18 years of age, children are excluded from this study.
- ECOG performance status < 2 (Karnofsky ≥60%, see Appendix A).
- Life expectancy >16 weeks.
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- Suitable target artery diameter(s), defined in the TriNav labelling as 1.5 to 3.5mm vessels, based upon pre-procedural imaging.
- 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.
- If extrahepatic disease is present (e.g. brain metastases), such disease must be stable, under treatment, or not an imminent threat to the patient's life or quality of life.
- Ability to understand and the willingness to sign a written informed consent document.
- Prior to study entry women of child-bearing potential must agree to not become pregnant, nurse a baby, or use any milk expressed for 2 weeks following radioembolization. Men must agree to not father a baby for 2 months after treatment with radioembolization (This is confirmed during the consenting process and documented when the patient signs the informed consent form. The effects of Yttrium-90 and radiation associated with the procedures, radiotracers, and subsequent imaging are known to have teratogenic effects on the developing human fetus. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother breastfeeding should be discontinued for the duration of study participation.)
- For HCC patients: Barcelona Clinic Liver Cancer Stage: A, B, C.
Who cannot join
- Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
- Unresolved toxicities related to cancer therapy that the investigator will continue and compromise patient safety.
- History of hepatic encephalopathy; history of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives, or atropine that cannot be managed medically.
- Uncontrolled intercurrent illness.
- Psychiatric illness/social situations that would limit compliance with study requirements.
- Prior external beam radiation treatment to the liver or prior intra-arterial liver-directed therapy including transarterial bland embolization, chemoembolization or radioembolization.
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- Contraindications to angiography and selective visceral catheterization, including bleeding diathesis or uncorrectable coagulopathy.
- > 50% of tumor involvement of the liver.
- Receipt of intervention for the Ampulla of Vater or compromise thereof.
- Child-Pugh B8 or greater.
- Evidence of thrombosis in the main portal vein.
- For CLM patients: evidence of cirrhosis or portal hypertension.
- For CLM: Clinically-evident ascites other than trace noted on imaging.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02245
About this study
Official title: A Prospective, Randomized, Open-Label Study to Examine The Effects of a Pressure-Enabled Drug Delivery Device on Radiotracer Distribution Compared to a Standard Microcatheter in the Context of Radioembolization
The purpose of the study is to determine if the type of catheter used in the mapping procedure prior to radioembolization improves the delivery of radioactivity to tumor(s) in participants with liver cancer.
The name of the devices involved in this study are:
- Pressure Enabled Drug Delivery (PEDD)/TriNav Infusion System
- Standard 2.4F microcatheter, not otherwise specified
Read the detailed description
This is a prospective, randomized, open-label, single-center, investigator-initiated study to determine if the type of catheter used to deliver the radiotracer in the mapping procedure improves the delivery of radioactive microspheres during radioembolization treatment for liver cancer.
Both catheters being used, the Pressure Enabled Drug Delivery (PEDD)/TriNav Infusion System and theStandard 2.4F microcatheter have been cleared for clinical use by the U.S. Food and Drug Administration.
Radioembolization for the treatment of liver tumors typically requires 2 separate procedures. The first procedure is called the mapping procedure. During the mapping procedure, the blood supply to the liver and tumor are evaluated with a type of x-ray called angiography. Once the optimal catheter position is determined for treatment, a "simulation" run is performed with the injection of a fluid that acts like the radiation that will be delivered to treat the tumors. This fluid is called a radiotracer. The study is looking to learn if the Pressure Enabled Drug Delivery device increases the ratio of radiotracer delivered to liver tumor tissue relative to normal liver tissue compared to a standard microcatheter. An improved delivery of radiotracer may indicate improved delivery of radioactive microspheres which may lead to improved tumor response rates and less liver toxicity
The research study procedures include assessments for eligibility, study treatment including evaluations, and follow-up visits.
Participants will undergo the study procedures in the normal course of their radioembolization procedure, with the addition of a second mapping procedure on the treatment day. Participants will be randomly assigned to one of two mapping procedures: Sequence A or Sequence B.
It is expected that about 10-20 people in total will take part in this research study.
TriSalus Life Sciences, Inc., a biotechnology and medical device company, is supporting this research study by providing funding.
- Being tested
- Standard microcatheter, PEDD device
- Keywords
- Liver Cancer, Hepatocellular Carcinoma, Metastatic Colorectal Cancer
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard microcatheterDevice
Small device used for mapping as part of radioembolization procedure
PEDD deviceDevice
Also called TriNav Infusion System catheter
Pressure enabled small device used for mapping as part of radioembolization procedure
| Study group | Role | What they receive |
|---|---|---|
| Sequence A: Standard microcatheter for Mapping #1 and PEDD device for Mapping #2. | Experimental | 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. Receives: Device: Standard microcatheter; Device: PEDD device |
| Sequence B: PEDD device for Mapping #1 and standard microcatheter for Mapping #2. | Experimental | 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. Receives: Device: Standard microcatheter; Device: PEDD device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiotracer distribution
The primary endpoint of the study is radiotracer distribution, as measured by tumor to normal liver (T:N) ratio. Using SPECT/CT images collected subsequent to radiotracer delivery in mapping procedures, the volumetric tumor to normal liver (T:N) ratio of 99mTc-MAA distribution will be calculated using advanced imaging processing software, such as MIM SurePlan MRT. The T:N ratio of 99mTc-MAA delivered via the standard microcatheter will be compared to the PEDD device for each patient. The T:N ratio will be calculated for each tumor as well as in aggregate for the three largest tumors as described in Section 12.
Measured: Up to 2 years
Secondary outcomes (2)
Mapping procedure comparison of Tumor to Normal (T:N) ratio between standard microcatheter and pressure-enabled delivery catheter
Compare the mapping procedure radiotracer T:N ratio to therapeutic microsphere T:N ratio for both the standard microcatheter and the PEDD device when both the radiotracer and therapeutic microspheres were delivered by the same catheter
Measured: Up to 2 years
Technical success of radiotracer delivery as measured by ability to deliver radiotracer
Technical success of radiotracer delivery of each catheter, where success is defined as the satisfactory positioning and delivery of radiotracer.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Mar 2022
- Primary completion16 Jul 2026
- Study completion16 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- TriSalus Life Sciences, Inc.
- Responsible party
- Principal investigator, Patrick D. Sutphin, M.D., Massachusetts General Hospital
- Investigators
- Patrick D Sutphin, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128032
- Sponsor's protocol ID
- 21-351
- Acronym
- PEDIR
- Status last verified
- Oct 2025
- First submitted
- 9 Nov 2021
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-Label Study to Examine The Effects of a Pressure-Enabled Drug Delivery Device on Radiotracer Distribution Compared to a Standard Microcatheter in the Context of Radioembolization
- ClinicalTrials.gov ID
- NCT05128032
- Acronym / sponsor ID
- PEDIR / 21-351
- Keywords
- Liver Cancer, Hepatocellular Carcinoma, Metastatic Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- TriSalus Life Sciences, Inc.
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 16 Jul 2026 (actual)
- Study completion
- 16 Jul 2026 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine if the type of catheter used in the mapping procedure prior to radioembolization improves the delivery of radioactivity to tumor(s) in participants with liver cancer.
The name of the devices involved in this study are:
- Pressure Enabled Drug Delivery (PEDD)/TriNav Infusion System
- Standard 2.4F microcatheter, not otherwise specified
Detailed description
This is a prospective, randomized, open-label, single-center, investigator-initiated study to determine if the type of catheter used to deliver the radiotracer in the mapping procedure improves the delivery of radioactive microspheres during radioembolization treatment for liver cancer.
Both catheters being used, the Pressure Enabled Drug Delivery (PEDD)/TriNav Infusion System and theStandard 2.4F microcatheter have been cleared for clinical use by the U.S. Food and Drug Administration.
Radioembolization for the treatment of liver tumors typically requires 2 separate procedures. The first procedure is called the mapping procedure. During the mapping procedure, the blood supply to the liver and tumor are evaluated with a type of x-ray called angiography. Once the optimal catheter position is determined for treatment, a "simulation" run is performed with the injection of a fluid that acts like the radiation that will be delivered to treat the tumors. This fluid is called a radiotracer. The study is looking to learn if the Pressure Enabled Drug Delivery device increases the ratio of radiotracer delivered to liver tumor tissue relative to normal liver tissue compared to a standard microcatheter. An improved delivery of radiotracer may indicate improved delivery of radioactive microspheres which may lead to improved tumor response rates and less liver toxicity
The research study procedures include assessments for eligibility, study treatment including evaluations, and follow-up visits.
Participants will undergo the study procedures in the normal course of their radioembolization procedure, with the addition of a second mapping procedure on the treatment day. Participants will be randomly assigned to one of two mapping procedures: Sequence A or Sequence B.
It is expected that about 10-20 people in total will take part in this research study.
TriSalus Life Sciences, Inc., a biotechnology and medical device company, is supporting this research study by providing funding.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A: Standard microcatheter for Mapping #1 and PEDD device for Mapping #2. | Experimental | Device: Standard microcatheter, Device: PEDD deviceParticipants 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. |
| Sequence B: PEDD device for Mapping #1 and standard microcatheter for Mapping #2. | Experimental | Device: Standard microcatheter, Device: PEDD deviceParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Known HCC or CLM that are not amenable to curative resection or thermal ablative techniques such as microwave ablation.
- Prior clinical decision for treatment by radioembolization.
- Disease that is visible on CT or MRI as well as measurable disease in the liver. Measurable is defined as at least one lesion in the expected treatment field that can be accurately measured in at least one dimension (longest diameter) as (≥1 cm) with CT scan or MRI.
- Age ≥18 years. Because there is limited data with respect to radioembolization in patients <18 years of age with respect to tumor dosimetry and associated adverse events participants <18 years of age, children are excluded from this study.
- ECOG performance status < 2 (Karnofsky ≥60%, see Appendix A).
Key exclusion criteria (13 listed)
- Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study.
- Unresolved toxicities related to cancer therapy that the investigator will continue and compromise patient safety.
- History of hepatic encephalopathy; history of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives, or atropine that cannot be managed medically.
- Uncontrolled intercurrent illness.
- Psychiatric illness/social situations that would limit compliance with study requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard microcatheterSmall device used for mapping as part of radioembolization procedure | Device | 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. |
| PEDD deviceAlso: TriNav Infusion System catheterPressure enabled small device used for mapping as part of radioembolization procedure | Device | 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. |
Primary outcome
Radiotracer distribution
Time frame: Up to 2 years
The primary endpoint of the study is radiotracer distribution, as measured by tumor to normal liver (T:N) ratio. Using SPECT/CT images collected subsequent to radiotracer delivery in mapping procedures, the volumetric tumor to normal liver (T:N) ratio of 99mTc-MAA distribution will be calculated using advanced imaging processing software, such as MIM SurePlan MRT. The T:N ratio of 99mTc-MAA delivered via the standard microcatheter will be compared to the PEDD device for each patient. The T:N ratio will be calculated for each tumor as well as in aggregate for the three largest tumors as described in Section 12.
2 secondary outcomes
Mapping procedure comparison of Tumor to Normal (T:N) ratio between standard microcatheter and pressure-enabled delivery catheter
Time frame: Up to 2 years
Technical success of radiotracer delivery as measured by ability to deliver radiotracer
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick D Sutphin, MD, PhD principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard microcatheter and PEDD device in people with Liver Cancer and Hepatocellular Carcinoma, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiotracer distribution (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.