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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Biological: Tc99m-MAA

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 chemotherapy and stereotactic body radiation therapy. However, arterial administration of radiation to these tumors may represent an alternative method of radiotherapy, with dose directly administered to the tumor. The potential radiation dose to the tumor and adjacent structures is not known.

This study aims to estimate the dose of radiation to tumor and adjacent structures in the chest via administration of a radiotracer called Tc99m-MAA. 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.

If this study is successful, the results will allow doctors to use the distribution of Tc99m-MAA to estimate radiation dose to tumors and adjacent structures in the setting of intra-arterial radiation therapy. This will provide information to plan future therapy with intra-arterial radioembolization for lung malignancies.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tc99m-MAA; 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	Biological: Tc99m-MAA; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Calculation of Tc99m-MAA uptake within the tumor and surrounding structures (radioactivity concentration)	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: BTG International Inc.
• Investigators: Principal Investigator: Eric Wehrenberg-Klee, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): July 1, 2024

Study Registration Dates

• First Submitted: September 20, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 9, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Lung Cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Hemorrhage; Signs and Symptoms, Respiratory; Hemoptysis; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Technetium Tc 99m Aggregated Albumin
• Other Study ID Numbers: 19-218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: MGH - Contact the Partners Innovations team at http://www.partners.org/innovation
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No