Pilot study of fibroblast activation factor expression in recurrent/progressive pancreatic cancer and mesothelioma using [68Ga]Ga-Fibroblast Activation Protein Inhibitor (FAPI)-46 PET imaging

Study Outline

This is a pilot study comparing a new PET imaging tracer, [68Ga]Ga-FAPI-46 (Fibroblast Activation Protein Inhibitor), with the current standard imaging tracer [18F]FDG for imaging pancreatic cancer and malignant pleural mesothelioma. The study will enrol approximately 30 patients at Sir Charles Gairdner Hospital in Western Australia.

The trial aims to determine whether [68Ga]Ga-FAPI-46 PET imaging can effectively detect Fibroblast Activation protein expression in advanced pancreatic cancer and mesothelioma cells. This is important because if successful, future research could examine using the FAPI agent with a different radioactive tag that could kill cancer cells instead of just imaging them, opening new treatment possibilities.

What’s Involved

All participants will:

• Undergo one additional PET/CT scan with [68Ga]Ga-FAPI-46 tracer within one week of their standard [18F]FDG PET scan
• Have a small amount of radioactive [68Ga]Ga-FAPI-46 injected through a needle in a hand or arm vein
• Rest for up to 3 hours while the tracer travels through the bloodstream and is taken up by cancer cells
• Spend approximately 30 minutes in the PET scanner
• Complete the visit in up to 4 hours total
• Have their medical records accessed over the next 12 months to follow up clinical treatment and imaging (no additional appointments required)

The additional PET scan is for research only and will not be used to change your treatment. Your standard [18F]FDG PET scan will be performed separately as part of your normal clinical care.

Eligibility

You may be eligible for this study if you:

• Are 18 years or older
• Have been diagnosed with pancreatic cancer which is locally advanced or recurrent/progressive, OR malignant pleural mesothelioma at initial diagnosis or suspected disease progression
• Have been referred for a clinical [18F]FDG PET/CT scan
• Are able to provide informed consent and undergo study procedures

You may not be eligible for this study if you:

• Are currently receiving treatment for pancreatic cancer or mesothelioma (including chemotherapy, radiotherapy or immunotherapy)
• Are pregnant at the time of PET scans
• Are unable to provide informed consent or undergo study procedures
• Have other active cancer

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Integrative Supportive Care Trial to Enhance Physical Activity in Malignant Pleural Effusion (The Australasian Malignant PLeural Effusion (AMPLE)-5 Trial)

Study Outline

This randomised controlled trial investigates the effects of an integrated supportive care program on physical activity levels and other outcomes in patients with malignant pleural effusion (MPE). Approximately 100 participants will be randomly assigned to either the intervention group, receiving a 12-week multidisciplinary supportive care program addressing nutrition, physical activity, and psychological well-being, or the control group, receiving standard medical care with referral to supportive services if indicated.

The primary outcome is the change in daily step count measured by an accelerometer, with secondary outcomes including quality of life, malnutrition risk, psychological well-being, and symptom burden.

What’s Involved

Participants will be randomly assigned to one of two groups:

• Integrated Supportive Care Program Group: Participants will attend counselling sessions at weeks 1, 4, and 8, each lasting about an hour. The multidisciplinary team, consisting of a dietitian, exercise physiologist/physiotherapist, and clinical psychologist/specially trained nurse, will develop individualised care plans based on the participant’s needs. Sessions will be conducted via telehealth or in-person if required.
• Standard Care Group: Participants will receive standard medical care as per their attending physician, with referral to supportive services if indicated. They will receive phone calls from the research team at weeks 4 and 8 to discuss any adverse events.

Both groups will continue to receive standard medical care from their treating physician throughout the study, including access to support services. The study will last for 13 weeks, with assessments conducted at baseline and post-intervention.

Eligibility

You may be eligible for this study if you:

• Are 19 years of age or older.
• Have a confirmed diagnosis of malignant pleural effusion.
• Have an estimated survival of at least 3 months.
• Are willing to comply with the study procedures.

You may not be eligible for this study if you:

• Are younger than 19 years old.
• Are unable to provide informed consent.
• Are unable to comply with the study protocol.
• Are pregnant or lactating.
• Have an ECOG performance status greater than 3.

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The Western Australia Asbestos Review Program

Study Outline

In this study, researchers will conduct yearly clinical assessments to track the health outcomes of individuals from Western Australia who have had exposure to asbestos over an extended period.

What’s Involved

Those who opt to participate in this study will be required to undergo an annual comprehensive evaluation, which includes an assessment of their general and lung health, tests to measure lung function, and a chest CT scan using an ultra-low dose to detect any asbestos-related lung diseases. Additionally, the Western Australian Asbestos Review Program (ARP) will conduct blood tests to identify potential markers that could aid in the early diagnosis of lung diseases. Each yearly appointment is expected to last approximately two hours. The ARP does not restrict participation based on age or the duration since the initial asbestos exposure, as the study aims to monitor as many exposed individuals as possible for an extended period.

The researchers anticipate that this study will yield valuable insights, enabling healthcare professionals to better characterise, diagnose, and comprehend diseases associated with asbestos exposure. The findings from this research may ultimately contribute to improving the health outcomes of future patients who have been impacted by asbestos exposure

Eligibility

You may be eligible for this study if you meet the following criteria: are a Western Australian resident aged 16 or above, and either have a history of occupational asbestos exposure, have previously lived in Wittenoom (the site of the asbestos mine), or have experienced a cumulative asbestos exposure exceeding 3 months and/or have radiological findings indicating the presence of an asbestos-related disease.

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Imaging biomarkers of response to immunotherapy in malignant mesothelioma

Study Outline

Immunotherapy targeting immune checkpoint molecules is revolutionising treatment of mesothelioma. A recent international clinical trial showed that people whose tumours showed more ‘PD-L1′ on biopsy seemed to benefit more, but this was not a close enough association to reliably direct treatment. This study will non-invasively image PD-L1 in people with mesothelioma before and during immunotherapy treatment. This may help us understand how treatments change PD-L1 epression over time and better guide treatment.

What’s Involved

Positron Emission Tomography (PET)/Computed Tomography (CT) with fluoro-deoxyglucose (FDG) is a standard scan used to detect mesothelioma. PET/CT scanning is done by injecting a small amount of radioactive material (called a tracer) through a vein, then imaging your body by passing you through a PET/CT scanner whilst you lie on your back. Participants will be asked to have between two and four ⁸⁹Zr-durva PET/CT scans to see where PD-L1 is present.

This trial will not affect your standard treatment. You will continue to receive the treatment recommended by your doctor.

Eligibility

You may be eligible for this trial if you have been diagnosed with pleural or peritoneal mesothelioma, you have not yet begun chemotherapy or radiotherapy and you have not received prior immune checkpoint blockade therapy.

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Linear Phase I Trials

Linear Clinical Research is a Phase 1 clinical trials unit which is on the Sir Charles Gairdner Hospital campus. People with mesothelioma may be eligible to participate in these clinical trials, usually after referral from their medical oncologist.

The International Association for the Study of Lung Cancer (IASLC) Prospective Malignant Pleural Mesothelioma Staging Project (9th Edition)

This study is collecting information that will improve the staging of mesothelioma. Earlier editions have led to changes in guidelines for the management of malignant mesothelioma.

The Australasian Malignant PLeural Effusion (AMPLE) Trial – 3: Comparing IPC with Talc Pleurodesis versus VATS

This randomised study compares two approaches for managing malignant pleural effusion: indwelling pleural catheter (IPC) with talc pleurodesis versus video-assisted thoracoscopic surgery (VATS).

The trial aims to determine which approach is more effective at preventing fluid re-accumulation and reducing the need for additional procedures. The study has completed the recruitment of its participants.

The Australasian Malignant PLeural Effusion (AMPLE)-4 Trial: Topical Antibiotic Prophylaxis for Infections of Indwelling Pleural Catheters in Patients with Malignant Pleural Effusions

This randomised study compares two approaches for preventing infection in patients with malignant pleural effusion who have an indwelling pleural catheter: regular application of topical mupirocin (antibiotic cream) versus standard IPC care.

The trial aims to determine whether topical mupirocin can reduce infection rates in this patient group. The study is active but no longer recruiting participants.

This phase 3 randomised study compares volrustomig (MEDI5752) in combination with carboplatin and pemetrexed chemotherapy against standard of care treatment in patients with advanced unresectable pleural mesothelioma.

The study has completed the recruitment of its participants.