First PITAC Procedure for Mesothelioma Performed in North America
A surgeon has performed the first pressurized aerosol chemotherapy (PITAC) for mesothelioma in North America, bringing a European innovation to U.S. patients.
A thoracic surgeon has performed the first pressurized intrathoracic aerosol chemotherapy (PITAC) procedure for mesothelioma in North America, marking a milestone for a technique developed in Europe over the past decade. The minimally invasive approach delivers chemotherapy as a pressurized mist directly into the pleural cavity, targeting malignant fluid buildup and tumor tissue while minimizing the systemic toxicity associated with intravenous chemotherapy.
How PITAC Works
The procedure is performed through video-assisted thoracoscopic surgery (VATS), using small incisions and camera guidance. Once access to the pleural cavity is established, carbon dioxide is introduced at 12 mmHg of pressure to create a controlled environment. A chemotherapy solution, typically cisplatin combined with doxorubicin, is then nebulized into the space over approximately five minutes.
The pressurized aerosol remains in contact with the pleural surfaces for 30 minutes, allowing the drug to penetrate tumor tissue more effectively than traditional lavage techniques. The pressure gradient enhances drug absorption while keeping doses low enough to avoid the nausea, immune suppression, and organ damage commonly associated with systemic chemotherapy.
No chest tube is routinely required after the procedure, and patients can typically return home the same day.
What Early Data Shows
PITAC was first performed in 2012 in Herne, Germany, developed alongside PIPAC (pressurized intraperitoneal aerosol chemotherapy), which targets abdominal cancers. A retrospective analysis of the earliest cases, published in PMC, examined five patients who received a combined 11 planned PITAC treatments between 2018 and 2021.
The results, while preliminary, showed measurable responses:
- One patient achieved stable disease for 11 months
- One patient’s malignant pleural effusion resolved with no recurrence at four weeks
- Histological examination showed treatment responses in pleural tissue samples
- Nine of 11 planned treatments were completed without major complications
The patients in this initial cohort had pleural disease from multiple cancer types, including mesothelioma, rectal cancer, breast cancer, and ovarian cancer. No serious adverse events were reported.
Why It Matters for People With Mesothelioma
Malignant pleural effusions, the buildup of fluid between the lung and chest wall caused by cancer, affect a significant proportion of people with pleural mesothelioma. The fluid causes shortness of breath, chest pain, and reduced quality of life. Current management options include draining the fluid, pleurodesis (sealing the space to prevent re-accumulation), or indwelling catheters.
PITAC offers a potential alternative that addresses both the fluid and the underlying tumor. By delivering chemotherapy directly to the affected surfaces, it could reduce effusions while simultaneously treating the cancer cells causing them.
For people with mesothelioma who cannot tolerate aggressive surgery or systemic chemotherapy, a low-toxicity procedure that can be repeated at regular intervals represents a meaningful expansion of treatment options.
The Path Forward
A Phase I clinical trial (NCT06421610), approved in May 2023 at the Odense PIPAC Center in Denmark, is currently recruiting up to 20 patients with malignant pleural effusions. The trial is evaluating PITAC’s safety, toxicity profile, effect on effusion volume, pain levels, breathlessness, and quality of life. Participants receive at least two PITAC sessions at four-week intervals.
No North American clinical trials specifically evaluating PITAC for mesothelioma have been announced as of early 2026. The first North American procedure represents a step toward broader adoption, but routine clinical use will require data from prospective trials demonstrating both safety and efficacy in larger patient populations.
The technique builds on the success of HIPEC, which has become an established treatment for peritoneal mesothelioma. Where HIPEC delivers heated chemotherapy during open abdominal surgery, PITAC achieves a similar targeted delivery in the chest through a minimally invasive approach.
References
PMC / National Library of Medicine. (2024). Pressurized Intrathoracic Aerosol Chemotherapy: Retrospective Analysis.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11661464/
ClinicalTrials.gov. (2023). Phase I PITAC Trial (OPC5).
https://clinicaltrials.gov/study/NCT06421610
CTSNet. (2024). PITAC Procedural Demonstration.
https://www.ctsnet.org/article/pitac-pressurized-intrathoracic-aerosol-chemotherapy
Reader Q&A
Frequently Asked Questions
What is PITAC?
Is PITAC available as a standard treatment?
How does PITAC compare to HIPEC?
What are the side effects of PITAC?
What is a treatment in research?
In research, a treatment is the independent variable manipulated by experimenters and applied to participants or experimental units to assess its effects, often compared to a control group receiving no treatment, placebo, or standard intervention. This approach isolates cause-and-effect relationships in fields like medicine, where treatments might involve drugs or therapies at varying levels or doses. Treatments enable evaluation of interventions’ impacts through randomized allocation to groups.
What are the 5 types of clinical trials?
Clinical trials fall into two main categories: interventional trials, which test treatments or interventions, and observational studies, which monitor participants without intervention. Common types of interventional trials include treatment trials testing new drugs, surgeries, or therapies; prevention trials evaluating ways to reduce disease risk; screening trials assessing detection methods; and diagnostic trials studying tools to identify diseases. Additional types are quality-of-life trials, which examine supportive care, and genetic trials assessing hereditary risks, while observational types include cohort, case-control, and cross-sectional studies. No single list specifies exactly five types, as classifications vary by objective. Search ClinicalTrials.gov for mesothelioma-specific trials.
What are the 4 types of research studies?
Medical research is typically classified into four main categories: basic research (fundamental investigation of disease mechanisms), clinical research (studies of treatments and interventions in people), epidemiological research (population-level disease patterns and risk factors), and secondary research (systematic reviews and meta-analyses of existing studies). Within clinical research specifically, studies are further divided into observational studies (case series, case-control, cohort, and cross-sectional designs) and interventional studies (randomized controlled trials). The choice of study type depends on the research question being addressed. For mesothelioma research, epidemiological studies have documented asbestos exposure patterns, while clinical trials test new treatment approaches for people with mesothelioma.
What is the study of treatments called?
Clinical trials are research studies that test medical, surgical, or behavioral interventions, such as new drugs or devices, in people to determine if they are safe and effective. These trials, a type of clinical research, compare new treatments to existing ones or standard care to assess improvements in outcomes or side effects. Observational studies, by contrast, monitor people without testing interventions. ClinicalTrials.gov lists ongoing trials, including those for mesothelioma.