Tc99m-MAA Bronchial Artery Injection During Bronchial Embolization for Pulmonary Mass Induced Hemoptysis for Dosimetry Planning
1 other identifier
interventional
8
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 lung-cancer
Started Aug 2020
Typical duration for phase_1 lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2019
CompletedFirst Posted
Study publicly available on registry
September 26, 2019
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedOctober 15, 2024
October 1, 2024
3.8 years
September 20, 2019
October 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Calculation of Tc99m-MAA uptake within the tumor and surrounding structures (radioactivity concentration)
2 years
Secondary Outcomes (2)
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
Number of patients experiencing immediate post-procedural adverse events associated with bronchial artery administration of Tc99m-MAA
2 years
Study Arms (1)
Tc99m-MAA
EXPERIMENTAL* 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- BTG International Inc.collaborator
Study Sites (1)
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Related Publications (1)
Wehrenberg-Klee E, An T, Heidari P, Huesa-Berral C, Dreher MR, Eldridge A, Fowers K, Schuemann J, Bertolet A. SPECT/CT Dosimetry of Bronchial Artery 99mTc Macroaggregated Albumin Injection in Pulmonary Malignancies: Feasibility Evaluation of Bronchial Artery 90Y Radioembolization. Radiology. 2025 Feb;314(2):e240331. doi: 10.1148/radiol.240331.
PMID: 39964268DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Wehrenberg-Klee, MD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 20, 2019
First Posted
September 26, 2019
Study Start
August 1, 2020
Primary Completion
June 1, 2024
Study Completion
July 1, 2024
Last Updated
October 15, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.