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Completed

NCT Number: NCT04105283

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tc99m-MAA

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.

Primary outcomes

  1. Calculation of Tc99m-MAA uptake within the tumor and surrounding structures (radioactivity concentration)

    Time frame: 2 years

Secondary outcomes

  1. 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)

    Time frame: 2 years

  2. Number of patients experiencing immediate post-procedural adverse events associated with bronchial artery administration of Tc99m-MAA

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • BTG International Inc.

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Sep 26, 2019
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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