Tc99m Macroaggregated Albumin Bronchial Artery Study

Not Applicable

Withdrawn

• Conditions: Malignant Neoplasm; Lung Cancer; Hemoptysis
• Interventions: Procedure: Technicium 99 MAA infusion

• Registration Number: NCT04555564
• Lead Sponsor: Johns Hopkins University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-18
• Status Verified: 2021-08
• Study Start: 2022-08-01
• Last Update Submitted: 2022-08-15
• Last Update Posted: 2022-08-18
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Technicium 99 MAA	Technicium 99 MAA infusion	Participants will receive bronchial artery administration of Technicium 99 MAA

Primary Outcome Measures

Name	Time	Method
Quantification of Tc99m-MAA uptake	12 months	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.