Tc99m Macroaggregated Albumin Bronchial Artery Study

Study Overview
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Brief Summary
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This is a single-arm, single-center, prospective pilot study to perform bronchial artery Tc-99m-MAA infusion to determine the predicted whole lung versus lung tumor dosimetry of a possible intra-arterial radioembolization.

Detailed Description
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This study is a prospective, single-arm pilot study for patients presenting with hemoptysis from lung cancers. Prior to a therapeutic bronchial artery embolization (standard therapy), Tc99m-MAA will be administered to the bronchial artery and an imaging will be obtained to determine the distribution of MAA. The primary objective will be quantification of Tc99m-MAA uptake within the tumor and surrounding structures (esophagus, bronchi, pericardium, spine). This is a purely descriptive study and no statistical comparison or correlation will be made. Dosimetry will be reported for each patient, as well as range and mean with standard deviation. Additional activity calculation methods and reporting metrics may additionally be used. Non-statistical comparison will be made to literature-reported external-beam radiation dose-related tumor response and adjacent-organ toxicities to develop a preliminary assessment of the potential for efficacy and anticipated safety-profile of Yittrium-90 bronchial artery radio-embolization.

Official Title
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Tc99m-Macroaggregated Albumin Bronchial Artery Injection During Bronchial Embolization for Pulmonary Mass Induced Hemoptysis for Dosimetry Planning

Conditions
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Hemoptysis, Malignant Neoplasm, Lung Cancer

Intervention / Treatment
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* Procedure: Technicium 99 MAA infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects 18 years of age and older Patients with known active lung cancer with a history of prior hemoptysis presenting for bronchial artery embolization will be considered. Patients must be presenting for secondary prophylaxis of hemoptysis Willing and able to understand and sign a written informed consent document. Willing and able to undergo all study procedures. Exclusion Criteria: Patients with current active hemoptysis Any acute or chronic inflammatory disease or medical conditions that in the investigator's opinion may interfere with the study procedures or the interpretation of the study results. If female, not of childbearing potential or negative serum β-human chorionic gonadotropin pregnancy test prior to radiotracer injection. If female, not nursing. Subjects who have exclusion criteria that would prevent them from receiving a CT scan or fluoroscopy, or administration of contrast. History of allergic reactions attributed to compounds of similar chemical or biologic composition to macro-aggregated albumin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm, prospective, single-center
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Technicium 99 MAA<br>Participants will receive bronchial artery administration of Technicium 99 MAA | Procedure: Technicium 99 MAA infusion<br>* 4mci of Technicium 99 MAA will be infused into the bronchial artery via a catheter prior to a standard therapy (bronchial artery embolization). The patient will undergo nuclear medicine imaging following this intervention to quantify MAA distribution within the lung tumor and adjacent lung tissue.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of Tc99m-MAA uptake | The primary objective will be quantification of Tc99m-MAA uptake (measured in Gray) within the tumor and surrounding structures (esophagus, bronchi, pericardium, spine). This is a purely descriptive study and no statistical comparison or correlation will be made. This assessment will be done for each participant at 12 months. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung cancer, lung metastasis, Bronchial artery embolization, MAA study, Dosimetry