OnCo
ideasIdea

Device-agnostic public trials of ablation technologies against surgery

Focused ultrasound, histotripsy, heat and electric-field ablation can destroy tumours without an incision, but each maker runs its own small study. Publicly-funded trials would compare them fairly against surgery.

A public trials programme comparing non-invasive and minimally invasive ablation (histotripsy, high-intensity focused ultrasound, microwave and radiofrequency ablation, irreversible electroporation) with surgical resection in indications where ablation is plausible: small hepatocellular carcinoma and liver metastases, small renal masses, localised prostate cancer, early pancreatic tumours in inoperable patients, and thyroid nodules. Trials are device-agnostic within a class, use oncological and functional co-primary endpoints, and are run by the surgical and interventional trials network. Manufacturers contribute devices and training but do not control design or data. Regulatory clearance of these devices has largely rested on technical success, not comparative cancer outcomes.

Hypothesis
Within five years the programme delivers randomised evidence in at least three indications on whether ablation achieves non-inferior local control and survival with better functional outcomes than resection, and at least one result changes guidelines.
Rationale
Trials such as COLLISION (thermal ablation versus resection for colorectal liver metastases) show that randomising ablation against surgery is feasible and informative; histotripsy and HIFU have reached the clinic with single-arm evidence only. Device-agnostic public trials are the only way to obtain comparative evidence companies will not fund.
What would test it
Launch two randomised trials (liver and kidney) with device-agnostic ablation arms and track accrual, local control and functional outcomes.
Maturity
early clinical
Who has to act
research
Cost to try
Large (over $50M)
Years to first evidence
5
Bottlenecks it attacks

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