Tc99m Macroaggregated Albumin Bronchial Artery Study

NCT04555564 | Withdrawn

• 1 other identifier: IRB00222311
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemoptysis; Malignant Neoplasm; Lung Cancer

Keywords

Lung cancer; lung metastasis; Bronchial artery embolization; MAA study; Dosimetry

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Study Arms (1)

Technicium 99 MAA

EXPERIMENTAL

Participants will receive bronchial artery administration of Technicium 99 MAA

Procedure: Technicium 99 MAA infusion

Interventions

Technicium 99 MAA infusion PROCEDURE

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.

Technicium 99 MAA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to macro-aggregated albumin

Sponsors & Collaborators

• Johns Hopkins University: lead
• Boston Scientific Corporation: collaborator

Related Publications (7)

• 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.

  PMID: 19727742 BACKGROUND

• 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.

  PMID: 19406667 BACKGROUND

• 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.

  PMID: 11888961 BACKGROUND

• 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.

  PMID: 27569207 BACKGROUND

• 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.

  PMID: 4893319 BACKGROUND

• 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.

  PMID: 13077512 BACKGROUND

• 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.

  PMID: 23839007 BACKGROUND

MeSH Terms

Conditions

Hemoptysis; Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Study Officials

• Ji Buethe, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm, prospective, single-center

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 18, 2020
• Study Start: August 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 18, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share