Hemoptysis, Lung Cancer, Malignant Neoplasm
Conditions
Keywords
Lung cancer, lung metastasis, Bronchial artery embolization, MAA study, Dosimetry
Brief 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.
Detailed 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.
Interventions
PROCEDURETechnicium 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.
Sponsors
Boston Scientific Corporation
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Single arm, prospective, single-center
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 β-human chorionic gonadotropin pregnancy test prior to radiotracer injection. * If female, not nursing. * Subjects who have
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantification of Tc99m-MAA uptake | 12 months | 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. |
Outcome results
None listed