Skip to main content
OpenTrials
Completed

NCT Number: NCT04200417

Chemoembolization for Lung Tumors

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Memoral Sloan Kettering Monmouth (Consent only), Middletown, New Jersey, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Chemoembolization

Procedure

Chemoembolization will be performed via the artery (bronchial, non-bronchial systemic, or pulmonary) that shows the greatest tumor enhancement on angiography. Chemoembolization will be performed using a lipiodol / mitomycin emulsion, followed by spherical particles.

mitomycin C

Drug

Mitomycin (5mg/m^2,maximum mitomycin dose 20 mg) will be dissolved in lipiodol at 2 mg/ml on the day of procedure.

Lipiodol

Drug

Mitomycin (5mg/m^2,maximum mitomycin dose 20 mg) will be dissolved in lipiodol at 2 mg/ml on the day of procedure.

Embospheres

Drug

Embospheres are non-resorbable spherical microspheres (trisacryl gelatin) that are FDA-approved for embolization of hypervascular tumors.

Primary outcomes

  1. Participant toxicity will be evaluated according to CTCAE v5.0

    Time frame: Up to 12 months post treatment

    Safety will be evaluated by participant toxicity according to CTCAE v5.0

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Phase I Study of Transarterial Chemoembolization of Lung Metastases

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 16, 2019
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.