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Lung TumorEarly Phase 1NCT05555342

A Novel Method for Treating Lung Met w/Combo of Electric Fields & Rad Therapy: A Single-Arm

A Early Phase 1 study testing Irreversible electroporation (IRE) ablation and Radiation Therapy in people with Lung Tumor and Metastatic Cancer, run by University of California, Irvine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase 0, pilot prospective study to determine the feasibility of combined irreversible electroporation (IRE) and radiation therapy in subjects with lung tumors with metastatic cancer of any histology. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Tumor, Metastatic Cancer
What is being tested?
Irreversible electroporation (IRE) ablation and Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
3 Jan 2023to 27 Oct 2024
Phase
Early Phase 1
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

  • Patients must have histologically or cytologically confirmed metastatic cancer of any histology. There must be a lung tumor present, although the lung tumor does not specifically need to have been biopsied.
  • Patients must have advanced disease (stage IV) or previously treated disease that has become progressive, recurrent, or metastatic.
  • Patients may have received any number of prior systemic or local therapies. There will be no prespecified washout period prior to IRE. However, systemic therapy will be halted while receiving IRE and radiation, and can be restarted following completion of radiation therapy.
  • Up to 3 lesions may be included for treatment. The selected lesion(s) should be amenable to ablation and irradiation and patients will be eligible for ablation and irradiation in the judgment of the treating radiologist and radiation oncologist. If more than one lesion is selected, they should be separated by at least 5 cm to minimize lung irradiation. The target lesion for treatment by IRE and radiation will be a tumor not previously treated by radiation. This target lesion must be measurable, defined as the ability to be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >10 mm with spiral CT scan. The upper limit to the target lesion is 6 cm maximal diameter, but it also must be planned to be encompassed entirely by an IRE ablative zone. Any number of IRE probes will be allowed such that the entire tumor can be ablated.
  • Must be age ≥ 18 years. Children are excluded from this study but will be eligible for future pediatric trials, if applicable.
  • 1. Both men and women and members of all races and ethnic groups are eligible for this trial. Non-English speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial.
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  • Performance status: ECOG performance status ≤2 (Karnofsky ≥50%).
  • Life expectancy of ≥3 months.
  • Adequate organ and marrow function as defined below. Labs should be performed within 14 days of treatment.
  • Platelets ≥50,000/mcL
  • Hemoglobin ≥8 g/dL
  • Absolute neutrophil count ≥1,000/mcL
  • INR <1.5
  • Female patients of childbearing potential must have a negative urine or serum pregnancy during screening. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • The effects of ionizing radiation (i.e. radiation therapy) on the developing human fetus are known to have the potential for congenital abnormalities and fetal harm. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and until completion of radiation therapy. Should a woman become pregnant or suspect she is pregnant during this period, she should inform her treating physician immediately.
  • 1. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
  • Has not undergone a hysterectomy or bilateral oophorectomy; or
  • Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
  • Patients must not have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis.
  • Ability to understand and willingness to sign a written informed consent document

Who cannot join

  • Patient's whose target lesion has been previously treated with radiation therapy.
  • Patients who have not recovered from adverse events due to prior anti-cancer therapy administered.
  • Patients may not be receiving any other investigational agents 2 weeks prior to enrollment and until end of all therapeutic interventions.
  • Patients with cardiac arrhythmias, pacemakers, or implanted defibrillator.
  • Patients with epilepsy.
  • Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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  • Patients must not be pregnant due to the potential for congenital abnormalities and fetal harm caused by ionizing radiation.
  • Patients with disease amenable to curative intent therapy.
  • Patient has a known additional malignancy that is progressing or requires active treatment; exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Chao Family Comprehensive Cancer Center University of California, Irvine

    Orange, California, 92868

Other trials in United States

About this study

Official title: A Novel Method for Treating Lung Metastases With the Combination of Electrical Fields and Radiation Therapy: A Single-Arm Pilot Study

This is a phase 0, pilot prospective study to determine the feasibility of combined irreversible electroporation (IRE) and radiation therapy in subjects with lung tumors with metastatic cancer of any histology. These are subjects who have advanced disease (stage IV) or previously treated disease that has become progressive, recurrent, or metastatic.

Being tested
Irreversible electroporation (IRE) ablation, Radiation Therapy
Keywords
lung metastasis, Stereotactic Ablative Radiotherapy, Percutaneous ablation, irreversible electroporation
Medical subject headings
Lung Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Irreversible electroporation (IRE) ablationProcedure or surgery

    IRE will be performed using the NanoKnife or Aliya System. CT or cone-beam CT will be used to direct electrode placement.

  • Radiation TherapyRadiation

    Moderate-dose radiation therapy to the target tumor(s) in 1 fraction.

Study groups in NCT05555342
Study groupRoleWhat they receive
IRE ablation and radiation therapyExperimentalPatients will be treated with IRE ablation directed at the target lesion on day 1. Moderate-dose, single-fraction radiation therapy will be delivered to the target lesion on day 8 to day 15.
Receives: Procedure: Irreversible electroporation (IRE) ablation; Radiation: Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility, measured as the number of patients completing both IRE and the single fraction of radiation

    Number of patients completing treatment of both IRE and the single fraction of radiation. Up to 6 replacements are allowed (total subjects 6-12)

    Measured: Up to 3 years

Secondary outcomes (10)

  1. Number of grade 3-5 adverse events

    Severe toxicity will be measured by cumulative CTCAE v5.0 grade 3-5 events. Evaluation of Grade 3-5 toxicity will be made at 30 days

    Measured: Up to 3 years

  2. Local failure at the treated site

    Local failure rate at the treated site will be determined using cumulative incidence rates with death as a competing event at 12 months after initiation of treatment

    Measured: Up to 3 years

  3. Duration of response

    The duration of response is measured from the time of treatment initiation until local failure is objectively documented

    Measured: Up to 3 years

  4. Progression-free survival

    Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Estimates at 6 and 12 months will be made.

    Measured: Up to 3 years

  5. Overall survival

    The duration of time from start of treatment to time of progression or death, whichever occurs first. Estimates at 6 and 12 months will be made.

    Measured: Up to 3 years

  6. Number of grade 1-5 adverse events

    Toxicity will be measured by cumulative CTCAE v5.0 grade 1-5 events. Evaluation of Grade 1-5 toxicity will be made at 30 days

    Measured: Up to 3 years

  7. Patient reported quality of life

    Mean summary score of the Functional Assessment of Cancer Therapy-Lung (FACT-L). Functional Assessment of Cancer Therapy-Lung (FACT-L) Scale is a 36-item self-reported instrument that measures multidimensional quality of life for lung cancer patients. Questions are scored on a 5-point Likert Scale. The FACT-L includes the FACT-G (general) assessment which is comprised of four subscales including Physical Well-Being (score = 0-28), Social/Family Well-Being (score= 0-28), Emotional Well Being (score = 0-24), and Functional Well-Being (score = 0-28), for a total score min/max = 0-108, plus, the Lung Cancer Subscale (nine lung cancer related items, score = 0-45). Total scores range from 0-136, with higher scores indicating better quality of life.

    Measured: Up to 3 years

  8. Forced vital capacity

    Pulmonary function is assessed by the volume change (mL) in the value of forced vital capacity (FVC)

    Measured: Up to 3 years

  9. Forced expiratory volume at 1 second (FEV1)

    Pulmonary function is assessed by volume change (mL) in the value of forced expiratory volume at 1 second (FEV1)

    Measured: Up to 3 years

  10. Diffusing capacity for carbon monoxide (DLCO)

    Pulmonary function is assessed by change in the value of diffusing capacity for carbon monoxide (DLCO) measured in mL/min/kPa

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2022
  2. Study start3 Jan 2023
  3. Primary completion29 Sep 2023
  4. Study completion27 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05555342
Sponsor's protocol ID
1723
Other IDs
UCI 21-222
Status last verified
May 2025
First submitted
20 Sep 2022
Last updated
14 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Harris JP, Boyd C, Shi M, Reilly M, Simon A, Seyedin SN, Chen WP, Nagasaka M, Nabar R, Abi-Jaoudeh N. Pilot Study of Combining Stereotactic Body Radiation Therapy with Pulsed Field Ablation for Oligometastatic/Oligoprogressive Lung Tumors. J Vasc Interv Radiol. 2025 Nov;36(11):1687-1695. doi: 10.1016/j.jvir.2025.08.005. Epub 2025 Aug 11.

    PubMed 40803526

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Irreversible electroporation (IRE) ablation and Radiation Therapy in people with Lung Tumor and Metastatic Cancer, run by University of California, Irvine at 1 site 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 20 inclusion and 9 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 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Feasibility, measured as the number of patients completing both IRE and the single fraction of radiation (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05555342, which also lists 1 linked publication.

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 14 May 2025.

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