HemoptysisNCT04555564
Tc99m Macroaggregated Albumin Bronchial Artery Study
A study testing Technicium 99 MAA infusion in people with Hemoptysis and Malignant Neoplasm, run by Johns Hopkins University.
Trial summary
This is a single-arm, single-center, prospective pilot study to perform bronchial artery Tc-99m-MAA infusion to determine the predicted whole lung versus lung tumor dosimetry of a possible intra-arterial radioembolization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemoptysis, Malignant Neoplasm, Lung Cancer
- What is being tested?
- Technicium 99 MAA infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 31 Dec 2024
- Phase
- Interventional
- 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 prior hemoptysis presenting for bronchial artery embolization will be considered.
- Patients must be presenting for secondary prophylaxis of hemoptysis
- 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.
- If female, not of childbearing potential or negative serum β-human chorionic gonadotropin pregnancy test prior to radiotracer injection.
- If female, not nursing.
- Subjects who have exclusion criteria that would prevent them from receiving a CT scan or fluoroscopy, or administration of contrast.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to macro-aggregated albumin
About this study
Official title: Tc99m-Macroaggregated Albumin Bronchial Artery Injection During Bronchial Embolization for Pulmonary Mass Induced Hemoptysis for Dosimetry Planning
This is a single-arm, single-center, prospective pilot study to perform bronchial artery Tc-99m-MAA infusion to determine the predicted whole lung versus lung tumor dosimetry of a possible intra-arterial radioembolization.
Read the detailed description
This study is a prospective, single-arm pilot study for patients presenting with hemoptysis from lung cancers. Prior to a therapeutic bronchial artery embolization (standard therapy), Tc99m-MAA will be administered to the bronchial artery and an imaging will be obtained to determine the distribution of MAA.
The primary objective will be quantification of Tc99m-MAA uptake within the tumor and surrounding structures (esophagus, bronchi, pericardium, spine). This is a purely descriptive study and no statistical comparison or correlation will be made. Dosimetry will be reported for each patient, as well as range and mean with standard deviation. Additional activity calculation methods and reporting metrics may additionally be used. Non-statistical comparison will be made to literature-reported external-beam radiation dose-related tumor response and adjacent-organ toxicities to develop a preliminary assessment of the potential for efficacy and anticipated safety-profile of Yittrium-90 bronchial artery radio-embolization.
- Conditions
- Hemoptysis, Malignant Neoplasm, Lung Cancer
- Being tested
- Technicium 99 MAA infusion
- Keywords
- Lung cancer, lung metastasis, Bronchial artery embolization, MAA study, Dosimetry
- Medical subject headings
- Hemoptysis, Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Technicium 99 MAA infusionProcedure or surgery
4mci of Technicium 99 MAA will be infused into the bronchial artery via a catheter prior to a standard therapy (bronchial artery embolization). The patient will undergo nuclear medicine imaging following this intervention to quantify MAA distribution within the lung tumor and adjacent lung tissue.
| Study group | Role | What they receive |
|---|---|---|
| Technicium 99 MAA | Experimental | Participants will receive bronchial artery administration of Technicium 99 MAA Receives: Procedure: Technicium 99 MAA infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of Tc99m-MAA uptake
The primary objective will be quantification of Tc99m-MAA uptake (measured in "Gray") within the tumor and surrounding structures (esophagus, bronchi, pericardium, spine). This is a purely descriptive study and no statistical comparison or correlation will be made. This assessment will be done for each participant at 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Aug 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: Study withdrawn in IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HemoptysisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, prospective, single-center
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Ji Buethe, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555564
- Sponsor's protocol ID
- IRB00222311
- Status last verified
- Aug 2021
- First submitted
- 14 Sep 2020
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chun JY, Belli AM. Immediate and long-term outcomes of bronchial and non-bronchial systemic artery embolisation for the management of haemoptysis. Eur Radiol. 2010 Mar;20(3):558-65. doi: 10.1007/s00330-009-1591-3. Epub 2009 Sep 2.
PubMed 19727742Wang GR, Ensor JE, Gupta S, Hicks ME, Tam AL. Bronchial artery embolization for the management of hemoptysis in oncology patients: utility and prognostic factors. J Vasc Interv Radiol. 2009 Jun;20(6):722-9. doi: 10.1016/j.jvir.2009.02.016. Epub 2009 May 5.
PubMed 19406667Swanson KL, Johnson CM, Prakash UB, McKusick MA, Andrews JC, Stanson AW. Bronchial artery embolization : experience with 54 patients. Chest. 2002 Mar;121(3):789-95. doi: 10.1378/chest.121.3.789.
PubMed 11888961Eldridge L, Moldobaeva A, Zhong Q, Jenkins J, Snyder M, Brown RH, Mitzner W, Wagner EM. Bronchial Artery Angiogenesis Drives Lung Tumor Growth. Cancer Res. 2016 Oct 15;76(20):5962-5969. doi: 10.1158/0008-5472.CAN-16-1131. Epub 2016 Aug 28.
PubMed 27569207Jonas AM, Carrington CB. Vascular patterns in primary and secondary pulmonary tumors in the dog. Am J Pathol. 1969 Jul;56(1):79-95. No abstract available.
PubMed 4893319CUDKOWICZ L, ARMSTRONG JB. The blood supply of malignant pulmonary neoplasms. Thorax. 1953 Jun;8(2):153-6. doi: 10.1136/thx.8.2.152. No abstract available.
PubMed 13077512Ricke J, Grosser O, Amthauer H. Y90-radioembolization of lung metastases via the bronchial artery: a report of 2 cases. Cardiovasc Intervent Radiol. 2013 Dec;36(6):1664-1669. doi: 10.1007/s00270-013-0690-3. Epub 2013 Jul 10.
PubMed 23839007
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tc99m-Macroaggregated Albumin Bronchial Artery Injection During Bronchial Embolization for Pulmonary Mass Induced Hemoptysis for Dosimetry Planning
- ClinicalTrials.gov ID
- NCT04555564
- Acronym / sponsor ID
- IRB00222311
- Conditions
- Hemoptysis, Malignant Neoplasm, Lung Cancer
- Keywords
- Lung cancer, lung metastasis, Bronchial artery embolization, MAA study, Dosimetry
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn in IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Sep 2020 (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 is a single-arm, single-center, prospective pilot study to perform bronchial artery Tc-99m-MAA infusion to determine the predicted whole lung versus lung tumor dosimetry of a possible intra-arterial radioembolization.
Detailed description
This study is a prospective, single-arm pilot study for patients presenting with hemoptysis from lung cancers. Prior to a therapeutic bronchial artery embolization (standard therapy), Tc99m-MAA will be administered to the bronchial artery and an imaging will be obtained to determine the distribution of MAA.
The primary objective will be quantification of Tc99m-MAA uptake within the tumor and surrounding structures (esophagus, bronchi, pericardium, spine). This is a purely descriptive study and no statistical comparison or correlation will be made. Dosimetry will be reported for each patient, as well as range and mean with standard deviation. Additional activity calculation methods and reporting metrics may additionally be used. Non-statistical comparison will be made to literature-reported external-beam radiation dose-related tumor response and adjacent-organ toxicities to develop a preliminary assessment of the potential for efficacy and anticipated safety-profile of Yittrium-90 bronchial artery radio-embolization.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, prospective, single-center
| Arm | Type | Receives |
|---|---|---|
| Technicium 99 MAA | Experimental | Procedure: Technicium 99 MAA infusionParticipants will receive bronchial artery administration of Technicium 99 MAA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects 18 years of age and older
- Patients with known active lung cancer with a history of prior hemoptysis presenting for bronchial artery embolization will be considered.
- Patients must be presenting for secondary prophylaxis of hemoptysis
- Willing and able to understand and sign a written informed consent document.
- Willing and able to undergo all study procedures.
Key exclusion criteria (6 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.
- If female, not of childbearing potential or negative serum β-human chorionic gonadotropin pregnancy test prior to radiotracer injection.
- If female, not nursing.
- Subjects who have exclusion criteria that would prevent them from receiving a CT scan or fluoroscopy, or administration of contrast.
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 |
|---|---|---|
| Technicium 99 MAA infusion4mci of Technicium 99 MAA will be infused into the bronchial artery via a catheter prior to a standard therapy (bronchial artery embolization). The patient will undergo nuclear medicine imaging following this intervention to quantify MAA distribution within the lung tumor and adjacent lung tissue. | Procedure or surgery | Technicium 99 MAA |
Primary outcome
Quantification of Tc99m-MAA uptake
Time frame: 12 months
The primary objective will be quantification of Tc99m-MAA uptake (measured in "Gray") within the tumor and surrounding structures (esophagus, bronchi, pericardium, spine). This is a purely descriptive study and no statistical comparison or correlation will be made. This assessment will be done for each participant at 12 months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Background: PubMed 19727742Chun JY, Belli AM. Immediate and long-term outcomes of bronchial and non-bronchial systemic artery embolisation for the management of haemoptysis. Eur Radiol. 2010 Mar;20(3):558-65. doi: 10.1007/s00330-009-1591-3. Epub 2009 Sep 2.
- Background: PubMed 19406667Wang GR, Ensor JE, Gupta S, Hicks ME, Tam AL. Bronchial artery embolization for the management of hemoptysis in oncology patients: utility and prognostic factors. J Vasc Interv Radiol. 2009 Jun;20(6):722-9. doi: 10.1016/j.jvir.2009.02.016. Epub 2009 May 5.
- Background: PubMed 11888961Swanson KL, Johnson CM, Prakash UB, McKusick MA, Andrews JC, Stanson AW. Bronchial artery embolization : experience with 54 patients. Chest. 2002 Mar;121(3):789-95. doi: 10.1378/chest.121.3.789.
- Background: PubMed 27569207Eldridge L, Moldobaeva A, Zhong Q, Jenkins J, Snyder M, Brown RH, Mitzner W, Wagner EM. Bronchial Artery Angiogenesis Drives Lung Tumor Growth. Cancer Res. 2016 Oct 15;76(20):5962-5969. doi: 10.1158/0008-5472.CAN-16-1131. Epub 2016 Aug 28.
- Background: PubMed 4893319Jonas AM, Carrington CB. Vascular patterns in primary and secondary pulmonary tumors in the dog. Am J Pathol. 1969 Jul;56(1):79-95. No abstract available.
- Background: PubMed 13077512CUDKOWICZ L, ARMSTRONG JB. The blood supply of malignant pulmonary neoplasms. Thorax. 1953 Jun;8(2):153-6. doi: 10.1136/thx.8.2.152. No abstract available.
- Background: PubMed 23839007Ricke J, Grosser O, Amthauer H. Y90-radioembolization of lung metastases via the bronchial artery: a report of 2 cases. Cardiovasc Intervent Radiol. 2013 Dec;36(6):1664-1669. doi: 10.1007/s00270-013-0690-3. Epub 2013 Jul 10.
- Individual participant dataSharing planned: No
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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.
Ji Buethe, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A study testing Technicium 99 MAA infusion in people with Hemoptysis and Malignant Neoplasm, run by Johns Hopkins University.
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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Quantification of Tc99m-MAA uptake (time frame: 12 months). 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 NCT04555564, which also lists 7 linked publications.
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 18 Aug 2022.