CompletedPhase 1NCT04105283

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

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.

Checked against the public recordLast updated Oct 15, 2024 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 1
U.S. locations1
SponsorMassachusetts General Hospital
01
Study overview

What this study is about

Purpose
Diagnostic
Study type
Interventional
Phase
Phase 1
Sponsor
Massachusetts General Hospital
Interventions being studied
Biological: Tc99m-MAA
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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 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 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Massachusetts General Hospital Cancer CenterBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 15, 2024. Always confirm current availability with the study team.

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