Clinical trial · Interventional
Tc99m-MAA Bronchial Artery Injection During Bronchial Embolization for Pulmonary Mass Induced Hemoptysis for Dosimetry Planning
NCT04105283CI-TRIAL-00081505completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tc99m-MAA | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Tc99m-MAA
- 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
- interventionNames
- Biological: Tc99m-MAA
Primary outcomes (1)
- measure
- Calculation of Tc99m-MAA uptake within the tumor and surrounding structures (radioactivity concentration)
- timeFrame
- 2 years
Secondary outcomes (2)
- measure
- 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)
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDWehrenberg-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. PMID 39964268