Lung CancerPhase 1NCT04105283
Tc99m-MAA Bronchial Artery Injection During Bronchial Embolization for Pulmonary Mass Induced Hemoptysis for Dosimetry Planning
A Phase 1 study testing Tc99m-MAA in people with Lung Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Tc99m-MAA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 1 Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
About this study
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.
Read the 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
- Being tested
- Tc99m-MAA
- Keywords
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tc99m-MAABiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Tc99m-MAA | Experimental | * 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 Receives: Biological: Tc99m-MAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculation of Tc99m-MAA uptake within the tumor and surrounding structures (radioactivity concentration)
Measured: 2 years
Secondary outcomes (2)
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)
Measured: 2 years
Number of patients experiencing immediate post-procedural adverse events associated with bronchial artery administration of Tc99m-MAA
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Aug 2020
- Primary completion1 Jun 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- BTG International Inc.
- Responsible party
- Principal investigator, Eric Wehrenberg-Klee, MD, Massachusetts General Hospital
- Investigators
- Eric Wehrenberg-Klee, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105283
- Sponsor's protocol ID
- 19-218
- Status last verified
- Oct 2024
- First submitted
- 20 Sep 2019
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39964268
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tc99m-MAA Bronchial Artery Injection During Bronchial Embolization for Pulmonary Mass Induced Hemoptysis for Dosimetry Planning
- ClinicalTrials.gov ID
- NCT04105283
- Acronym / sponsor ID
- 19-218
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- BTG International Inc.
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 26 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tc99m-MAA | Experimental | Biological: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tc99m-MAATc99m-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. | Biological | Tc99m-MAA |
Primary outcome
Calculation of Tc99m-MAA uptake within the tumor and surrounding structures (radioactivity concentration)
Time frame: 2 years
2 secondary outcomes
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
Number of patients experiencing immediate post-procedural adverse events associated with bronchial artery administration of Tc99m-MAA
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 39964268Wehrenberg-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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Wehrenberg-Klee, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tc99m-MAA in people with Lung Cancer, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculation of Tc99m-MAA uptake within the tumor and surrounding structures (radioactivity concentration) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04105283, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.