Tc99m Macroaggregated Albumin Bronchial Artery Study

Lung Cancer Clinical Trial

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

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Hemoptysis
• Lung Cancer
• Malignant Neoplasm
• Neoplasms

• NCT number: NCT04555564
• Study type: Interventional
• Source: Johns Hopkins University
• Status: Withdrawn
• Phase: N/A
• Start date: August 1, 2022
• Completion date: December 31, 2024