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Withdrawn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
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
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
NCT ID
NCT04555564
First Posted
September 14, 2020
Last Updated
August 15, 2022
Sponsor
Johns Hopkins University
Collaborators
Boston Scientific Corporation
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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Tc99m Macroaggregated Albumin Bronchial Artery Study
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