Chemoembolization for Lung Tumors

Completed · Phase 1

Conditions studied: Lung Metastases, Endobronchial Metastases, Pleural Metastases, Mediastinal Metastases

In brief

This study is being done to determine if it is safe to perform lung chemoembolization and if the lung chemoembolization procedure can successfully deliver chemotherapy to lung tumors.

Key facts

Study ID

NCT04200417

Run by

Memorial Sloan Kettering Cancer Center

People needed

10

Starts

2019-12-13

Expected to finish

2022-04-19

Last updated by the study team

2025-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Lung, endobronchial, pleural, or mediastinal metastases that are not responding to systemic chemotherapy, and that are not amenable to ablation, resection, or SBRT.
• At least 18 years old.
• ECOG performance status 0 or 1

You may not qualify if…

• Primary lung cancer
• >50% of a lung is replaced with tumor
• Oxygen saturation <92% on room air
• FEV1 <60%
• Pulmonary hypertension (diagnosed or suspected on echocardiography, CT, 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 (dyspnea, volume overload)
• Left bundle branch block (contraindication to pulmonary angiography)
• Renal failure (eGFR <30 mL/min/1.73m\^2)
• Pregnancy
• Breastfeeding
• Altered mental status that would interfere with consent or follow-up
• Platelets < 100,000 (after transfusion, if needed)
• INR>2 (after transfusion, if needed)
• Hemoglobin <7 (after transfusion, if needed)
• Hyperthyroidism (contraindication to lipiodol)
• Planned radioactive iodine imaging or therapy (contraindication to lipiodol)
• Allergy to lipiodol or mitomycin
• Allergy to iodinated contrast that can not be treated with steroid / diphenhydramine premedication
• Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results

Where it is running

• Memoral Sloan Kettering Monmouth (Consent only) — Middletown, New Jersey, United States
• Memorial Sloan Kettering Cancer Center @ Commack (Consent Only) — Commack, New York, United States
• Memoral Sloan Kettering Westchester (Consent only) — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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