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

Phase 1

Completed

• Conditions: Lung Cancer
• Interventions: Biological: Tc99m-MAA

• Registration Number: NCT04105283
• Lead Sponsor: Massachusetts General Hospital

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.

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 Timeline

• Study First Submitted: 2019-09-20
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-26
• Study Start: 2020-08-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-07-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-09
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tc99m-MAA	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

Primary Outcome Measures

Name	Time	Method
Calculation of Tc99m-MAA uptake within the tumor and surrounding structures (radioactivity concentration)	2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States