Status:
COMPLETED
Tc99m-MAA Bronchial Artery Injection During Bronchial Embolization for Pulmonary Mass Induced Hemoptysis for Dosimetry Planning
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
BTG International Inc.
Conditions:
Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 dos...
Detailed 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 ch...
Eligibility Criteria
Inclusion
- 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 β-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
- 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
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04105283
Start Date
August 1 2020
End Date
July 1 2024
Last Update
October 15 2024
Active Locations (1)
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1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114