Tc99m Macroaggregated Albumin Bronchial Artery Study

August 15, 2022 updated by: Johns Hopkins University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Technicium 99 MAA
Participants will receive bronchial artery administration of Technicium 99 MAA
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of Tc99m-MAA uptake
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Ji Buethe, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2022

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

September 14, 2020

First Submitted That Met QC Criteria

September 14, 2020

First Posted (Actual)

September 18, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 15, 2022

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00222311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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