BridgeMD
New treatment option for Lung Non-Small Cell Carcinoma
Official title Phase II Trial of Lung Chemoemobolization
ClinicalTrials.gov ID: NCT05672108
What this study is testing
What is Ethiodized Oil?
Ethiodized Oil is an investigational medicine, being studied as a potential treatment for lung non-small cell carcinoma.
Also referred to as Ethiodol, Iodized Oil.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II trial evaluates how well transarterial chemoembolization (TACE) works for treating patients with non-small cell lung cancer or lung metastases. TACE is a minimally invasive procedure that involves injecting chemotherapy directly into an artery that supplies blood to tumors, and then blocking off the blood supply to the tumors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Lung cancer or lung metastases, with lung, endobronchial, pleural, or mediastinal tumors that are progressing on systemic therapy (or the patient...
- Lung-dominant disease (majority of active tumor volume is in the chest)
- At least 18 years old
You likely can't join if
- Eastern Cooperative Oncology Group (ECOG) performance status \> 2
- Oxygen saturation \< 92% on room air
- Forced expiratory volume in 1 second (FEV1) \< 60%
- No measurable treatable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (for example, unable to measure tumor size on...
- Life expectancy \< 6 months
- Pulmonary hypertension (diagnosed or suspected on echocardiography, CT, magnetic resonance imaging [MRI], or direct pressure measurement)
See the full eligibility criteria
- Lung cancer or lung metastases, with lung, endobronchial, pleural, or mediastinal tumors that are progressing on systemic therapy (or the patient cannot tolerate systemic therapy), and that are not amenable to...
- Lung-dominant disease (majority of active tumor volume is in the chest)
- At least 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status \> 2
- Oxygen saturation \< 92% on room air
- Forced expiratory volume in 1 second (FEV1) \< 60%
- No measurable treatable disease, per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (for example, unable to measure tumor size on CT, or lung nodules are all \< 1 cm)
- Life expectancy \< 6 months
- Pulmonary hypertension (diagnosed or suspected on echocardiography, CT, magnetic resonance imaging [MRI], or direct pressure measurement)
- Recent pulmonary embolism (within 3 months)
- Pulmonary arteriovenous malformation
- Active lung infection (pneumonia, empyema, or lung abscess requiring therapy within 1 month)
- Symptomatic heart failure (American College of Cardiology [ACC]/American Heart Association [AHA] stage C or D)
- Left bundle branch block (contraindication to pulmonary angiography)
- Renal failure (estimated glomerular filtration rate [eGFR] \< 30 mL/min/1.73 m\^2)
- Pregnancy or intent to become pregnant
- Breast feeding
- Altered mental status that would interfere with consent or follow-up
- Platelets \< 50,000 (after transfusion, if needed)
- International normalized ratio (INR) \> 2 (after transfusion, if needed)
- Hemoglobin \< 7 (after transfusion, if needed)
- Hyperthyroidism or history of hyperthyroidism, including subclinical hyperthyroidism (contraindication to lipiodol)
- Planned radioactive iodine imaging or therapy (contraindication to lipiodol)
- Allergy to lipiodol or mitomycin
- Allergy to iodinated contrast that cannot be treated with steroid / diphenhydramine premedication
- Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product, or that would affect subject safety
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.