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

NCT ID: NCT04105283

Last Updated: 2024-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2024-07-01

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Tc99m-MAA

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BTG International Inc.

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eric Wehrenberg-Klee, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eric Wehrenberg-Klee, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39964268 (View on PubMed)

Other Identifiers

19-218

Identifier Type: -

Identifier Source: org_study_id