Tc99m Macroaggregated Albumin Bronchial Artery Study

Lung Cancer Clinical Trial

Official title:

Tc99m-Macroaggregated Albumin Bronchial Artery Injection During Bronchial Embolization for Pulmonary Mass Induced Hemoptysis for Dosimetry Planning

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04555564
• Other study ID #: IRB00222311
• Status: Withdrawn
• Phase: N/A
• Start date: August 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: August 2021
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Hemoptysis
• Lung Cancer
• Malignant Neoplasm
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Boston Scientific Corporation

References & 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. — View Citation

CUDKOWICZ L, ARMSTRONG JB. The blood supply of malignant pulmonary neoplasms. Thorax. 1953 Jun;8(2):153-6. — View 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. Epub 2016 Aug 28. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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