NCT04105283CompletedPhase 1
Tc99m-MAA Bronchial Artery Injection During Bronchial Embolization for Pulmonary Mass Induced Hemoptysis for Dosimetry Planning
Source: ClinicalTrials.gov · Last updated 15 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 20 Sept 2019
- Start date
- 1 Aug 2020
- Primary completion date
- 1 Jun 2024
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Lung cancer
- NCT number
- NCT04105283
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 8
- From 1 Aug 2020 to the primary completion date, 1 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects who have exclusion criteria that would prevent them from receiving a CT scan or fluoroscopy, or administration of contrast.
Other illness
- 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.
- Patients with severe pulmonary hypertension.
Lab values
- History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to macro-aggregated albumin
- Platelets \< 30
- INR \> 3.0
Other
- Patients with current active hemoptysis
- Glomerular filtration rate \< 30
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Cancer Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.