CancerNCT07298096
A Prospective Single Center, Single Arm, Single-institution Registry That Aims to Assess the Safety and Quality of Life Benefits of Computer-assisted Vacuum Thrombectomy (CAVT) in the Treatment of Cancer Patients With Intermediate Risk Pulmonary Embolism (PE)
A study testing Aspiration Thrombectomy in people with Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to gather information about the quality of life benefits of cancer patients with intermediate risk PE who underwent thrombectomy. The safety of thrombectomy in this patient population will also be studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Aspiration Thrombectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2026to 30 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients with current or prior diagnosis of cancer. Histopathologic or radiologic imaging findings of primary or metastatic cancer are acceptable,
- Confirmed PE, based on computed tomographic pulmonary angiography (CTPA) imaging showing a filling defect in at least one main or proximal lobar pulmonary artery
- Classification of intermediate risk PE as defined by the institutional PERT algorithm
- Candidate for standard of care pulmonary thrombectomy
- Age greater than or equal to 18 years. The devices for mechanical thrombectomy are not suitably sized for pediatric patients.
- ECOG performance status less than or equal to 3
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- Patients must have adequate organ and marrow function as defined below:
- 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.
- Platelets ≥ 30,000/mcL
- As these procedures can be performed without the use of iodinated contrast, there are no specific requirements for renal function
- 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.
- All lines of prior systemic therapy are permissible. Standard concurrent chemotherapy, immunotherapy, or targeted therapy are permissible.
- 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.
Who cannot join
- Hemodynamic instability with any of the following present:
- Cardiac arrest
- 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
- Patients on ECMO
- History, imaging or hemodynamic findings consistent with chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis
- Imaging evidence or other evidence that suggests, in the opinion of the Investigator, that catheter-based intervention is not appropriate for the patient
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- Including but not limited to large volume lung metastases, especially in vascular distribution, large volume pulmonary infarct
- Allergy, hypersensitivity, or heparin induced thrombocytopenia (HIT)
- Severe active infection (e.g. sepsis) requiring treatment at time of enrollment
- Life expectancy <90 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030
Varshana Gurusamy, MD, 832-350-1456, vgurusamy@mdanderson.org
Varshana Gurusamy, MD
About this study
The goal of this clinical research study is to gather information about the quality of life benefits of cancer patients with intermediate risk PE who underwent thrombectomy. The safety of thrombectomy in this patient population will also be studied.
Read the detailed description
Primary Objective:
To assess the change in the Post Venous Thromboembolism Functional Status (PFVS, see Appendix) score at the time of discharge.
Secondary Objectives:
- To evaluate quality of life outcomes in patients undergoing thrombectomy by assessing changes in RV/LV ratio from baseline to 48 hours and 90 days post-procedure.
- To compare PE-related mortality versus all-cause mortality.
- To assess the incidence of device-related complications and rate of major bleeding events.
- To assess safety by determining the incidence of major adverse events within 7 days post-treatment.
- To compare pre- and post-procedure oxygen requirements and six-minute walk test (6MWT) performance in ambulatory patients.
- To evaluate radiographic changes over time on CT imaging, including parenchymal perfusion and RV/LV ratio in patients undergoing different treatment, at three-time points baseline, 48 hours, and 90 days.
- To compare BORG Dyspnea Scale scores between pre- and 90-day post-treatment.
- To evaluate the rate of PE recurrence within 90 days.
- To evaluate changes in residual volume of PE from baseline to follow-up imaging.
- To assess the incidence and severity of bleeding events using the BARC (Bleeding Academic Research Consortium) classification, and to explore associations between bleeding events and patients' chemotherapy or immunotherapy regimens through subgroup analysis.
- To characterize the histopathologic features of retrieved thrombus specimens, categorizing them as either bland thrombus or tumor thrombus, and further classifying tumor thrombi by histologic origin, such as gastrointestinal (GI) or genitourinary (GU) malignancies.
- To evaluate the reduction in RV/LV ratio on 48-hour post-treatment CT.
- Conditions
- Cancer
- Being tested
- Aspiration Thrombectomy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspiration ThrombectomyProcedure or surgery
All participants in this study will undergo standard of care aspiration thrombectomy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Penumbra Element Sheath | Experimental | Not described Receives: Procedure: Aspiration Thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start8 Jan 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Varshana Gurusamy, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298096
- Sponsor's protocol ID
- 2025-0830
- Other IDs
- NCI-2025-08931
- Status last verified
- Sep 2026
- First submitted
- 19 Dec 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single Center, Single Arm, Single-institution Registry That Aims to Assess the Safety and Quality of Life Benefits of Computer-assisted Vacuum Thrombectomy (CAVT) in the Treatment of Cancer Patients With Intermediate Risk Pulmonary Embolism (PE)
- ClinicalTrials.gov ID
- NCT07298096
- Acronym / sponsor ID
- 2025-0830
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 23 Dec 2025 (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.
The goal of this clinical research study is to gather information about the quality of life benefits of cancer patients with intermediate risk PE who underwent thrombectomy. The safety of thrombectomy in this patient population will also be studied.
Detailed description
Primary Objective:
To assess the change in the Post Venous Thromboembolism Functional Status (PFVS, see Appendix) score at the time of discharge.
Secondary Objectives:
- To evaluate quality of life outcomes in patients undergoing thrombectomy by assessing changes in RV/LV ratio from baseline to 48 hours and 90 days post-procedure.
- To compare PE-related mortality versus all-cause mortality.
- To assess the incidence of device-related complications and rate of major bleeding events.
- To assess safety by determining the incidence of major adverse events within 7 days post-treatment.
- To compare pre- and post-procedure oxygen requirements and six-minute walk test (6MWT) performance in ambulatory patients.
- To evaluate radiographic changes over time on CT imaging, including parenchymal perfusion and RV/LV ratio in patients undergoing different treatment, at three-time points baseline, 48 hours, and 90 days.
- To compare BORG Dyspnea Scale scores between pre- and 90-day post-treatment.
- To evaluate the rate of PE recurrence within 90 days.
- To evaluate changes in residual volume of PE from baseline to follow-up imaging.
- To assess the incidence and severity of bleeding events using the BARC (Bleeding Academic Research Consortium) classification, and to explore associations between bleeding events and patients' chemotherapy or immunotherapy regimens through subgroup analysis.
- To characterize the histopathologic features of retrieved thrombus specimens, categorizing them as either bland thrombus or tumor thrombus, and further classifying tumor thrombi by histologic origin, such as gastrointestinal (GI) or genitourinary (GU) malignancies.
- To evaluate the reduction in RV/LV ratio on 48-hour post-treatment CT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Penumbra Element Sheath | Experimental | Procedure: Aspiration Thrombectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients with current or prior diagnosis of cancer. Histopathologic or radiologic imaging findings of primary or metastatic cancer are acceptable,
- Confirmed PE, based on computed tomographic pulmonary angiography (CTPA) imaging showing a filling defect in at least one main or proximal lobar pulmonary artery
- Classification of intermediate risk PE as defined by the institutional PERT algorithm
- Candidate for standard of care pulmonary thrombectomy
- Age greater than or equal to 18 years. The devices for mechanical thrombectomy are not suitably sized for pediatric patients.
Key exclusion criteria (10 listed)
- Hemodynamic instability with any of the following present:
- Patients on ECMO
- History, imaging or hemodynamic findings consistent with chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis
- Imaging evidence or other evidence that suggests, in the opinion of the Investigator, that catheter-based intervention is not appropriate for the patient
- Allergy, hypersensitivity, or heparin induced thrombocytopenia (HIT)
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 |
|---|---|---|
| Aspiration ThrombectomyAll participants in this study will undergo standard of care aspiration thrombectomy. | Procedure or surgery | Treatment with Penumbra Element Sheath |
Primary outcome
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Varshana Gurusamy, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspiration Thrombectomy in people with Cancer, run by M.D. Anderson Cancer Center 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 13 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 4 Sep 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Varshana Gurusamy, MD (832-350-1456, vgurusamy@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs) (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2026.