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

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tc99m-MAA
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Cancer focused on measuring Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tc99m-MAA

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 20, 2019
Last Updated
September 10, 2021
Sponsor
Massachusetts General Hospital
Collaborators
BTG International Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04105283
Brief Title
Tc99m-MAA Bronchial Artery Injection During Bronchial Embolization for Pulmonary Mass Induced Hemoptysis for Dosimetry Planning
Official Title
Tc99m-MAA Bronchial Artery Injection During Bronchial Embolization for Pulmonary Mass Induced Hemoptysis for Dosimetry Planning
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
BTG International Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
Lung Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tc99m-MAA
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Tc99m-MAA
Intervention Description
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 Outcome Measure Information:
Title
Calculation of Tc99m-MAA uptake within the tumor and surrounding structures (radioactivity concentration)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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
Title
Number of patients experiencing immediate post-procedural adverse events associated with bronchial artery administration of Tc99m-MAA
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Wehrenberg-Klee, MD
Phone
617-724-4000
Email
ewehrenberg-klee@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Wehrenberg-Klee, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Wehrenberg-Klee, MD
Phone
617-724-4000
Email
ewehrenberg-klee@partners.org
First Name & Middle Initial & Last Name & Degree
Eric Wehrenberg-Klee, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.partners.org/innovation

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

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