Clinical trial NCT04555564: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Hemoptysis
Malignant Neoplasm
Lung Cancer
Keywords: Lung cancer
lung metastasis
Bronchial artery embolization
MAA study
Dosimetry
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2020-09-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm, prospective, single-center
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Quantification of Tc99m-MAA uptake
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Ji Buethe, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.