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Tc99m-MAA for Lung Cancer
Phase 1
Recruiting
Led By Eric Wehrenberg-Klee, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial will help researchers determine if a particle called macro-aggregated albumin (MAA) can be used to estimate the dose of radiation to tumor and adjacent structures. MAA is labelled with technetium 99m (Tc99m).
Who is the study for?
This trial is for adults with active lung cancer who have coughed up blood and are undergoing bronchial artery embolization. Participants must not be nursing, women should either not be able to bear children or have a negative pregnancy test, and all must consent to the study procedures.Check my eligibility
What is being tested?
The study tests Tc99m-MAA's use in dosimetry planning by injecting it during bronchial embolization. It aims to estimate radiation doses that tumors and nearby tissues might receive in future treatments but offers no direct therapeutic benefit now.See study design
What are the potential side effects?
Since Tc99m-MAA is used for imaging rather than treatment, significant side effects aren't expected from this agent itself. However, standard risks associated with bronchial artery embolization may still apply.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Calculation of Tc99m-MAA uptake within the tumor and surrounding structures (radioactivity concentration)
Secondary outcome measures
Number of patients experiencing immediate post-procedural adverse events associated with bronchial artery administration of Tc99m-MAA
Abdomen
Trial Design
1Treatment groups
Experimental Treatment
Group I: Tc99m-MAAExperimental Treatment1 Intervention
Tc99m-MAA will be administered by selective or supra-selective arterial injection via the bronchial artery or branches thereof.
Administration will occur over a period of 30-240 seconds
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Who is running the clinical trial?
BTG International Inc.OTHER
42 Previous Clinical Trials
3,062 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,939 Previous Clinical Trials
13,199,505 Total Patients Enrolled
Eric Wehrenberg-Klee, MDPrincipal Investigator - Massachusetts General Hospital
Massachusetts General Hospital, Massachusetts General Physicians Organization Inc
1 Previous Clinical Trials
30 Total Patients Enrolled
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