Tc99m Macroaggregated Albumin Bronchial Artery Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-12-31

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.

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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.

Conditions

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Hemoptysis Malignant Neoplasm Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm, prospective, single-center

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Technicium 99 MAA

Participants will receive bronchial artery administration of Technicium 99 MAA

Group Type EXPERIMENTAL

Technicium 99 MAA infusion

Intervention Type PROCEDURE

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.

Interventions

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Technicium 99 MAA infusion

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.

Intervention Type PROCEDURE

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.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to macro-aggregated albumin

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No