New Clot-Busting procedure could ease breathing for cancer patients
NCT ID NCT07298096
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 3 times
Summary
This study looks at whether a computer-assisted vacuum procedure to remove blood clots from the lungs is safe and improves quality of life for cancer patients with a moderate-risk pulmonary embolism. About 25 adults with cancer and a confirmed clot in a major lung artery will take part. Researchers will track side effects and how patients feel after the procedure.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients with current or prior diagnosis of cancer. Histopathologic or radiologic imaging findings of primary or metastatic cancer are acceptable, 2. Confirmed PE, based on computed tomographic pulmonary angiography (CTPA) imaging showing a filling defect in at least one main or proximal lobar pulmonary artery 3. Classification of intermediate risk PE as defined by the institutional PERT algorithm 4. Candidate for standard of care pulmonary thrombectomy 5. Age greater than or equal to 18 years. The devices for mechanical thrombectomy are not suitably sized for pediatric patients. 6. ECOG performance status less than or equal to 3 7. Patients must have adequate organ and marrow function as defined below: 1. absolute neutrophil count ≥ 1,000/mcL If ANC value is below 1,000/mcL, patient may be included if in the opinion of investigator, low ANC is due to ongoing chemotherapy and/or that it would not interfere with safe delivery of procedure or with the interpretation of study results. 2. Platelets ≥ 30,000/mcL 8. As these procedures can be performed without the use of iodinated contrast, there are no specific requirements for renal function 9. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: Women \<50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization. Women ≥ 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \>1 year ago, had chemotherapy-induced menopause with last menses \>1 year ago, or underwent surgical sterilization. 10. All lines of prior systemic therapy are permissible. Standard concurrent chemotherapy, immunotherapy, or targeted therapy are permissible. 11. Ability to understand and the willingness to sign a written informed consent document. Patients being treated with emergency thrombectomy who are unable to consent prior to their procedure can be enrolled if the informed consent is provided and signed within 72 hours of the procedure. Exclusion Criteria: 1. Hemodynamic instability with any of the following present: 1. Cardiac arrest 2. Obstructive shock or persistent hypotension defined as systolic blood pressure (BP) \<90 mmHg or an acute drop in systolic BP ≥40 mmHg for \>15 min, or requiring vasopressor or inotropic support to achieve a systolic BP ≥90 mmHg 2. Patients on ECMO 3. History, imaging or hemodynamic findings consistent with chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis 4. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, that catheter-based intervention is not appropriate for the patient a. Including but not limited to large volume lung metastases, especially in vascular distribution, large volume pulmonary infarct 5. Allergy, hypersensitivity, or heparin induced thrombocytopenia (HIT) 6. Severe active infection (e.g. sepsis) requiring treatment at time of enrollment 7. Life expectancy \<90 days
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of Texas M. D. Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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