Tc99m Macroaggregated Albumin Bronchial Artery Study

Johns Hopkins University

Status

Withdrawn

Conditions

Malignant Neoplasm

Lung Cancer

Hemoptysis

Treatments

Procedure: Technicium 99 MAA infusion

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04555564

IRB00222311

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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