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Tc99m Macroaggregated Albumin Bronchial Artery Study

Primary Purpose

Hemoptysis, Malignant Neoplasm, Lung Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Technicium 99 MAA infusion
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hemoptysis focused on measuring Lung cancer, lung metastasis, Bronchial artery embolization, MAA study, Dosimetry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Technicium 99 MAA

    Arm Description

    Participants will receive bronchial artery administration of Technicium 99 MAA

    Outcomes

    Primary Outcome Measures

    Quantification of Tc99m-MAA uptake
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    September 14, 2020
    Last Updated
    August 15, 2022
    Sponsor
    Johns Hopkins University
    Collaborators
    Boston Scientific Corporation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04555564
    Brief Title
    Tc99m Macroaggregated Albumin Bronchial Artery Study
    Official Title
    Tc99m-Macroaggregated Albumin Bronchial Artery Injection During Bronchial Embolization for Pulmonary Mass Induced Hemoptysis for Dosimetry Planning
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Study withdrawn in IRB
    Study Start Date
    August 1, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Johns Hopkins University
    Collaborators
    Boston Scientific Corporation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemoptysis, Malignant Neoplasm, Lung Cancer
    Keywords
    Lung cancer, lung metastasis, Bronchial artery embolization, MAA study, Dosimetry

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single arm, prospective, single-center
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Technicium 99 MAA
    Arm Type
    Experimental
    Arm Description
    Participants will receive bronchial artery administration of Technicium 99 MAA
    Intervention Type
    Procedure
    Intervention Name(s)
    Technicium 99 MAA infusion
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Quantification of Tc99m-MAA uptake
    Description
    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.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ji Buethe, MD
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    19727742
    Citation
    Chun JY, Belli AM. Immediate and long-term outcomes of bronchial and non-bronchial systemic artery embolisation for the management of haemoptysis. Eur Radiol. 2010 Mar;20(3):558-65. doi: 10.1007/s00330-009-1591-3. Epub 2009 Sep 2.
    Results Reference
    background
    PubMed Identifier
    19406667
    Citation
    Wang GR, Ensor JE, Gupta S, Hicks ME, Tam AL. Bronchial artery embolization for the management of hemoptysis in oncology patients: utility and prognostic factors. J Vasc Interv Radiol. 2009 Jun;20(6):722-9. doi: 10.1016/j.jvir.2009.02.016. Epub 2009 May 5.
    Results Reference
    background
    PubMed Identifier
    11888961
    Citation
    Swanson KL, Johnson CM, Prakash UB, McKusick MA, Andrews JC, Stanson AW. Bronchial artery embolization : experience with 54 patients. Chest. 2002 Mar;121(3):789-95. doi: 10.1378/chest.121.3.789.
    Results Reference
    background
    PubMed Identifier
    27569207
    Citation
    Eldridge L, Moldobaeva A, Zhong Q, Jenkins J, Snyder M, Brown RH, Mitzner W, Wagner EM. Bronchial Artery Angiogenesis Drives Lung Tumor Growth. Cancer Res. 2016 Oct 15;76(20):5962-5969. doi: 10.1158/0008-5472.CAN-16-1131. Epub 2016 Aug 28.
    Results Reference
    background
    PubMed Identifier
    4893319
    Citation
    Jonas AM, Carrington CB. Vascular patterns in primary and secondary pulmonary tumors in the dog. Am J Pathol. 1969 Jul;56(1):79-95. No abstract available.
    Results Reference
    background
    PubMed Identifier
    13077512
    Citation
    CUDKOWICZ L, ARMSTRONG JB. The blood supply of malignant pulmonary neoplasms. Thorax. 1953 Jun;8(2):153-6. doi: 10.1136/thx.8.2.152. No abstract available.
    Results Reference
    background
    PubMed Identifier
    23839007
    Citation
    Ricke J, Grosser O, Amthauer H. Y90-radioembolization of lung metastases via the bronchial artery: a report of 2 cases. Cardiovasc Intervent Radiol. 2013 Dec;36(6):1664-1669. doi: 10.1007/s00270-013-0690-3. Epub 2013 Jul 10.
    Results Reference
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