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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04105283
• Other study ID #: 19-218
• Status: Recruiting
• Phase: Phase 1
• Start date: August 1, 2020
• Est. completion date: July 1, 2024

Study information

• Verified date: April 2024
• Source: Massachusetts General Hospital
• Contact: Eric Wehrenberg-Klee, MD
• Phone: 617-724-4000
• Email: ewehrenberg-klee[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study will evaluate the administration of a particle called macro-aggregated albumin (MAA) labelled with the radiotracer technetium 99m (Tc99m) as a proxy to estimate the anticipated dose of radiation to tumor and adjacent structures. Administration of this labeled MAA will not have a therapeutic benefit on the participant's cancer. Administration will help researchers determine if arterial administration of radiation may be feasible for lung cancer in the future.

Description:

This research study is a Pilot Study, which is the first time investigators are examining this study intervention. As mentioned above, standard of care treatment for Stage III lung cancer includes chemotherapy and stereotactic body radiation therapy. However, arterial administration of radiation to these tumors may represent an alternative method of radiotherapy, with dose directly administered to the tumor. The potential radiation dose to the tumor and adjacent structures is not known. This study aims to estimate the dose of radiation to tumor and adjacent structures in the chest via administration of a radiotracer called Tc99m-MAA. Tc99m-MAA is a particle that is used to assess blood flow distribution and has a similar size to the particles that are utilized for arterial delivery of radiation therapy, also called radioembolization. Tc99m-MAA is currently used to estimate radiation dosimetry prior to arterial radiotherapy administration for liver malignancies. If this study is successful, the results will allow doctors to use the distribution of Tc99m-MAA to estimate radiation dose to tumors and adjacent structures in the setting of intra-arterial radiation therapy. This will provide information to plan future therapy with intra-arterial radioembolization for lung malignancies.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 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 hemoptysis presenting for standard of care bronchial artery embolization will be considered.
• Patients must be presenting for secondary prophylaxis of hemoptysis.
• If female, not of childbearing potential or negative serum ß-hCG pregnancy test prior to CTA chest and radiotracer injection.
• If female, not nursing.
• 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.
• Subjects who have exclusion criteria that would prevent them from receiving a CT scan or fluoroscopy, or administration of contrast.
• History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to macro-aggregated albumin
• Patients with severe pulmonary hypertension.
• Glomerular filtration rate < 30
• Platelets < 30
• INR > 3.0

Related Conditions & MeSH terms

• Hemoptysis
• Lung Cancer

Intervention

Biological:
• Tc99m-MAA
Tc99m-MAA is a particle that is used to assess blood flow distribution and has a similar size to the particles that are utilized for arterial delivery of radiation therapy, also called radioembolization. Tc99m-MAA is currently used to estimate radiation dosimetry prior to arterial radiotherapy administration for liver malignancies.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	BTG International Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculation of Tc99m-MAA uptake within the tumor and surrounding structures (radioactivity concentration)		2 years
Secondary	Number of patients experiencing off-target administration of Tc99m-MAA to distant organs (as assessed by radioactivity concentration assessed in regions of interest in distant extremities, head, abdomen)		2 years
Secondary	Number of patients experiencing immediate post-procedural adverse events associated with bronchial artery administration of Tc99m-MAA		2 years