Chemoembolization for Lung Tumors (NCT04200417) | Clinical Trial Compass
CompletedPhase 1
Chemoembolization for Lung Tumors
United States10 participantsStarted 2019-12-13
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 sa…
What they're measuring
1
Participant toxicity will be evaluated according to CTCAE v5.0