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Tc99m Macroaggregated Albumin Bronchial Artery Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04555564
Recruitment Status : Not yet recruiting
First Posted : September 18, 2020
Last Update Posted : August 30, 2021
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hemoptysis Malignant Neoplasm Lung Cancer Procedure: Technicium 99 MAA infusion Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, prospective, single-center
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Tc99m-Macroaggregated Albumin Bronchial Artery Injection During Bronchial Embolization for Pulmonary Mass Induced Hemoptysis for Dosimetry Planning
Estimated Study Start Date : August 1, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04555564


Contacts
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Contact: Ji Buethe, MD 410-614-5182 jbuethe1@jhmi.edu
Contact: Beatriz Kohler, RN, MPH, MBA 410 614 4212 bkohler@jhmi.edu

Sponsors and Collaborators
Johns Hopkins University
Boston Scientific Corporation
Investigators
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Principal Investigator: Ji Buethe, MD Johns Hopkins University
More Information
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Publications:

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04555564    
Other Study ID Numbers: IRB00222311
First Posted: September 18, 2020    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Lung cancer
lung metastasis
Bronchial artery embolization
MAA study
Dosimetry
Additional relevant MeSH terms:
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Neoplasms
Hemoptysis
Lung Diseases
Respiratory Tract Diseases
 Hemorrhage
Pathologic Processes
Signs and Symptoms, Respiratory